Total 55 it manager job vacancies in Quality Assurance / Control category in D22 Jurong, Jurong Island, Tuas

Job Overview

Ensures that all products of the company meet consistent standards. Plan and implement quality control tests. Also inspect at various stages in production and formulate reports on their key findings to strike the best solution as and when needed.

Responsibility and Duties

• Overall, in-charge of the QC Department and its adherence to the QHSE System Procedures.
• Settle quality issues with customers.
• Keep, control, and confirm formulation and blending procedures including new products in the OASIS System.
• Participate in the root cause analysis and in the formulation of corrective and preventive actions.
• Approve affected nonconforming lot disposition in the absence of Plant Manager or Business Head.
• Confirm and provide resources for the laboratory and other QC needs.
• NCF report coordination and monitoring.
• Coordinate nonconforming product for recall to Production, Plant Manager and Production Admin.
• Implement corrective actions and preventive actions as instructed.

Requirement

• Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology.
• A minimum of 5 years QC experience in chemical manufacturing industry.
• Ability to work independently and collaboratively.
• Ability to work in a fast-paced environment and manage deadlines.
• Good analytical and problem-solving skills.
• Proficiency in Microsoft Office Applications
• Strong interpersonal and communication skills

Qualifications & experience

• Degree in Engineering preferably Chemical or Mechanical
• Minimum 5 years working experience in manufacturing environment, preferably in Quality. Knowledge of ISO 9000, ISO 14001 and ISO/TS 16949 Computer Literate Able to work independently and a team player

Tasks & responsibilities

• Set department objectives and targets to support the achievement of company objectives and goals.
• Manage activities of incoming inspection to assure that materials used meet quality requirements.
• Oversee the product inspection activities within the company and QA activities within the department. Ensure that measuring and test equipment are calibrated and in good condition as required.
• Manage activities of outgoing inspection (including 100% firewall activities) to assure that products shipped to customers meet customer requirements.
• Establish, review and approve quality control methods and procedures to ensure that products processed adhere to customer specifications.
• Responsible for the management and monitoring of customer complaints. Coordinate with responsible departments for its resolution and response to customer.
• Liaise with suppliers on quality issues and Promote quality, environmental and safety awareness.
• Attend to customers’ quality enquiry or complaints; and prepare the necessary 8D or relevant report(s) to customer. Control further processing of non-conforming products and /or stop processes until product or process deficiency has been corrected.
• Initiate quality improvements programs and coordinate with different departments or external parties such as suppliers for its successful implementation.
• Establish, maintain and ensure consistent implementation of quality, environment and safety management systems such as ISO 9001, IATF 16949, ISO 14001, safety regulations, etc. Represent management as QMR /EMR in the implementation of the systems.

Benefits

• Working hour from 0800-1730
• Transport provided in Lakside MRT & Tuas Crescent MRT
• Leave entitlement start from 16 days up to 20 days.

The APAC Quality Manager maintains and optimizes the quality management system for the Asia Pacific region in support of commercial and logistics operations. This role will assess regulatory and business requirements and drive continuous improvement activities, ensuring the QMS fulfills both regulatory and customer requirements. In addition, the incumbent will also be responsible for the following:

• The complaint handling system for both regulated and non-regulated products based on the global complaint handling process.
• Represent the QMS as the Quality Management Representative per ISO requirements
• Serves as the primary point of contact for Notified Body audits and regulatory agency inspections
• Maintains and improves the site document management control, CAPA, internal audit, and supplier audit processes
• Supports the Quality Notification, Global Field Safety Notification & Ship Hold processes
• Organizes and conducts quality-related training to internal employees and distributors
• Maintains the Singapore controlled drug and poison licenses for the import and release of controlled drug products in Singapore.
• Supports Veterinary certificates or other government agency licenses activities for the Asia Pacific distribution center operation
• Manages the secondary assembly program at the Singapore Distribution Center

How You’ll Make an Impact:

• Ensures the QMS for Asia Pacific region is effective and aligned with the Complany Quality Policy and quality objectives, fulfills both regulatory and customer requirements
• Supports the commercial organization for the supplier audit program.
• Maintains controlled drug licenses and execute operation control on the release of controlled drug products.
• Support export documentation such as coordinating of the Veterinary certificate and poison licenses to support distribution center operation.
• Supports Australia, New Zealand and Korea import permit activities
• Assess and resolve gaps between regulations and the quality management system
• Maintains, optimizes, and improves current complaint handling system based on global complaint handling policy
• Responsible for post-market actions based on divisions’ CAPA plan and local regulation requirements. Support Quality Notification, Global Field Safety Notification & Ship Hold
• Be responsible for managing local SOPs according to Global SOPs. Maintain document control process
• Organize internal and external audits of the quality management system

What You Bring:

• Bachelor degree in Pharmacy. Professional pharmacist or intermediate certificate of clinical examination is preferred. Pharmacist registered with the Singapore Pharmacy Council
• At least 7 years' work experience in QA with 3 years management experience.
• Strong planning/organization skills
• Personnel management skills
• Good spoken and written English ability
• Strong ability to work effectively with diverse responsibilities
• Excellent interpersonal communication skills
• SAP ERP experience is a plus

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

#LI-GT1

Interested candidates, please submit your application through the Bio-Rad Careers website:

https://careers.bio-rad.com/jobs/quality-mgr-asia-pacific-singapore

COMPANY DESCRIPTION

As Singapore's leading supermarket retail player and a household name close to all, we have grown with you over the years. It is now your turn to grow an exciting new career and fulfil your aspirations with us. Join us as we embark on a journey to make lives better for our customers, community, environment and employees.

At NTUC FairPrice, we offer you more than just a job. We are committed in giving our employees a rewarding career through comprehensive development opportunities. We promise a wonderful workplace culture with ample opportunities for growth at different levels of your career. Every of our 10,000 employees across Singapore is important.

If the prospect of working in an organization at the forefront of retail technology and innovation excites you, look no further.

Grow your career with us today and make a difference.

RESPONSIBILITIES

This role will lead a team at the executives and team leader levels; a critical role in establishing and enforcing product safety and quality standards. The incumbent is responsible for Retail Business Product Compliance and E-commerce businessquality assurance and he/ she is expected to:

• Assist the manager in leading and manage product safety and quality team to ensurecompliance with the food safety standards and regulations.
• Stay updated on industry best practices and advancements in product safety and qualitymanagement
• Develop and implement product safety and quality policies, procedures and guidelines
• Conduct inspections and internal audits to ensure adherence to product safety protocols and evaluate the effectiveness of product safety and quality systems
• Monitor and analyze data to identify trends and areas for improvement
• Collaborate with cross-functional teams to address quality issues and implement correctiveactions
• Develop and deliver training programs on product safety and quality control
• Manage the end-to-end E-commerce operations, including website compliance, product listings and delivery functions requirements.

QUALIFICATIONS

• Degree in Food Science, Chemistry, Biotechnology or its equivalent.
• Preferably with 3 years relevant QA experience.
• Strong knowledge of product safety regulations and standards
• Experience with food safety and quality management systems
• Working knowledge of HACCP and/or ISO 22000 will be a distinct advantage.
• Good interpersonal skills with the attributes of a team player and a keen eye for details.
• Strong analytical and problem-solving abilities
• Excellent communication and interpersonal skills
• Possess a positive attitude and learning mindset.
• Ability to work cross-functionally and collaborate effectively with teams

OTHER INFORMATION

• Work location: FairPrice Hub (next to Joo Koon MRT station)
• Working hours: Monday - Friday, 8:30am - 6pm

Please note that your application will be sent to and reviewed by the direct employer - FairPrice

Role:

A Quality Assurance Manager at HOPE Technik will play a crucial role in ensuring the highest standards of quality for robotics, automation, and special vehicle projects. This individual will be responsible for leading and developing the Quality team, implementing quality assurance policies, and continuously improving processes to meet and exceed industry standards.

Key Responsibilities:

1. Team Leadership and Development: Build, train, and lead a team of quality assurance specialists.
   Foster a culture of continuous improvement and learning within the team.
   Conduct performance reviews and facilitate professional development opportunities.
   
2. Quality Assurance Strategy and Implementation: Develop and implement quality assurance policies and procedures.
   Collaborate with engineering and project management teams to integrate quality assurance into all phases of the development lifecycle.
   Ensure quality objectives are met by setting, monitoring, and enforcing standards and protocols.
   
3. Project Support and Quality Control: Provide expert guidance and support in quality planning for new projects, particularly in robotics, automation, and special vehicles.
   Oversee the inspection and testing of products to ensure adherence to established quality standards.
   Directly manage critical issues with product quality, providing immediate corrective actions and long-term solutions.
   
4. Continuous Improvement: Regularly review and analyze quality data and feedback to identify trends and areas for improvement.
   Implement innovative solutions and quality improvement practices.
   Stay informed of the latest industry trends, technologies, and quality assurance methodologies.
   
5. Compliance and Documentation: Ensure all quality assurance activities comply with industry regulations and standards.
   Maintain comprehensive documentation of quality assurance activities, tests, and outcomes for accountability and continuous learning.
   
6. Stakeholder Engagement: Communicate effectively with all levels of the organization, including senior management, engineering teams, and project managers.
   Build relationships with suppliers and external partners to ensure quality standards are understood and met.
   

Qualifications:

• Bachelor's or master's degree in Engineering, Quality Management, or a related field.
• Proven experience in quality assurance, preferably in the fields of robotics, automation, or vehicle engineering.
• Strong leadership skills with experience building and managing teams.
• Excellent problem-solving, organizational, and communication skills.
• Knowledge of quality assurance methodologies, tools, and regulations.
• Certification in Quality Management (e.g., CQM, CQE) is a plus.

Summary

The Senior Manager, Quality Assurance is responsible for overseeing the Singapore site’s QMS as Site Quality Leader and Quality Management Representative. The position will provide guidance and support to the Singapore site’s quality team and will work closely with the Director of Quality, VP of Operations, and APAC regional business partners.

Key Accountabilities

• Appointed as the Singapore Quality Management Representative and Singapore Quality Site Leader for ISO 9001:2015 QMS.
• Ensure effectiveness and compliance to ISO 9001:2015 and various regulatory requirements as needed.
• Lead site quality team to drive operation and product quality improvements via data driven metrics.
• Oversee and support supplier quality, SCAR, product inspection, equipment calibration, CAPA, complaint investigation, change control, LMS training, and NPI activities.
• Chair quality management reviews and manage Internal & External audits.
• Support global quality system process integration, harmonization, and simplification. Managing local implementation and changes.
• Manage employee recruitment and development, performance management, and motivate team to achieve departmental objectives and goals.
• Escalate and manage any significant events such as safety, product shipping holds due to quality, regulatory, or any compliance issue.
• Lead or support identified special projects and key initiatives as needed.
• Work cross-functionally to achieve Singapore site objectives.

Requirements

• 8+ years of experience in Quality Management Systems within the medical device or pharmaceutical industry or under an ISO 13485:2016 or ISO 9001:2015 QMS.
• 5+ years of management experience.
• Knowledge of regulatory requirements and standards relevant to manufacturing such as (ISO45001/OHSAS18001 and ISO14001)
• Strong customer focus with complaint investigation, significant event reporting and CAPA skills.
• Internal Auditor certification.
• Strong data analysis skills and proficiency in electronic data management systems.
• Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Proficiency in SAP, Microsoft Excel, Word, and PowerPoint.

The Regional Trade Compliance Manager is responsible for ensuring the import or export of products and materials complies with the regulations within a region. This includes assisting in the deployment of regional and/or localized trade compliance procedures and guidelines that will assure compliance with import and export regulations, executing audit and risk assessment programs including corrective action plans and providing leadership in strategic projects that affect the supply chain to ensure proper/advantageous structuring of transactions. In addition to developing and ensuring process adherence, the role will act as a key knowledge point for all trade compliance issues and take a lead in the training and development of key stakeholders.

How You’ll Make an Impact:

• Maintains and evaluates the region’s compliance status with various regulatory bodies including customs, export control and applicable tax authorities. Ensuring proper documentation and procedures are maintained in accordance with regulations.
• Reviews internal controls, develops processes, administers the compliance audit program, and oversees corrective action plans for the region. Identifies compliance gaps and recommends process improvements.
• Assists in establishing and maintaining localized policies and procedures for compliance with import and export regulations as well as ensuring broad Company awareness of these requirements.
• Identifies and develops business processes to address compliance risks, with a focus on continuous process improvements to increase efficiency and improve performance to customers.
• Responsible for monitoring and reporting KPIs and metrics to senior management and daily reporting of import and export compliance for the region.
• Sets overall budget, operational strategy and priorities for assigned area of responsibility.
• Prioritizes and manages projects in the region for both import and export compliance which involves defining the project scope, budget, scheduling and execution of project risk.

What You Bring:

• Bachelor’s or advanced degree in International Business, Business Administration or Supply Chain management.
• Customs broker license.
• At least 10 years trade compliance experience, with minimum 5 years' of management experience and trade compliance for multiple countries or in a global environment.
• Expert working knowledge of import and export regulations across the region, including Import Licensing, Export Licensing, Free Trade Agreements, HTS and Export Control Classification, Country of Origin, Valuation, Transfer Pricing, Authorized Economic Operator, Customs Trade Partnership Against Terrorism, Approved Exporter.
• Knowledge and ability to handle other Government Agency requirements applicable to Bio-Rad products, such as, but not limited to health registration agencies, veterinary controls and other related Export and Impart regulations within the region and countries.
• Experience with global trade management software and systems, and with implementation and scaling of trade automation tools including but not limited to SAP-GTS.
• Experience writing and submitting binding rulings and a proven record of designing and implementing value added import/export policies and processes.
• Experience with audits and disclosure practices.
• Experience working in the Medical Device, Pharmaceutical, Life Sciences or Diagnostic industry highly preferred.
• Demonstrated strong leadership, communication, analytical and people management skills.
• Exceptional verbal and written communication skills and interpersonal skills at all levels in the organization.
• Results orientation and strong sense of accountability.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

#LI-JT1

Interested candidates, please submit your application through the Bio-Rad Careers website:

https://careers.bio-rad.com/jobs/regional-trade-compliance-manager-singapore

Who we are:

Brdgx is the Asia payment access for businesses to Send and receive payments through local payment networks. We help financial institutions, merchants and technology platforms to expand their business reach to China and Southeast Asia by enabling access to local payment solutions. Our B2B digital treasury solution enables clients to execute their international transaction with speed and coverage.

We are looking for:

A leader to build the compliance foundation of the company by overseeing and executing our company's compliance requirements in customer due diligence and . He/she will also play a vital role in shaping the company's business roadmap by leading the company's expansion plan in Asia.

Jobscope:

· Review, draft and update the company’s compliance policies and procedures in accordance to the latest regulatory requirements and market practices related but not limited to KYC/AML/CTF

· Review and check Customer Due Diligence (CDD) information of clients and carry out Enhanced Due Diligence (EDD) cases and relevant KYC documents submitted by business.

· Oversees the company's compliance operations and on-going transaction monitoring process with recommendations

· Be the primary contact for regulators and banking partners in existing or new markets

· Communicate with third parties, including financial institutions and regulators, to fulfil regulatory compliance requirements

· Undertake risk assessment on the company's new product offering from a compliance perspective

· Manage the company compliance records, reporting process, and communicate with relevant external parties

· Provide advice to frontline and other relevant business units on compliance related matters

Qualification:

· University or Diploma graduate with work experience in banking, payment, or regulated financial institutions

· Possess at least 3 to 5 years of working experience in compliance related work

· Experience and knowledge of the operations of the external name screening devices / tools for compliance screening and transaction monitoring

· Strong skill and in-depth knowledge of CDD requirements for client onboarding and on-going KYC review based on MAS payment regulations

· Possess of the qualification / certification of the Enhanced Competency Framework on Anti-Money Laundering and Counter-Terrorist Financing is preferable

· A driven team player with a strong sense of collaborative success and a mindset of rendering quality service attitude

· Fluent in English. Chinese language ability is a plus

About Infosys:

Infosys is a global leader in next-generation digital services and consulting. We enable clients in 50 countries to navigate their digital transformation. With over three decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.

Visit www.infosys.com to see how Infosys (NYSE: INFY) can help your enterprise navigate your next.

Short Description:

If your passion is to build solutions that really make a difference to enterprises, the community and your world, Infosys is the right place for you.

Roles and Responsibilities:

As a Principal Consultant, you will anchor the enterprise level testing efforts, all the way from maturity assessment of enterprise testing processes, technology landscape, analyze, provide recommendations, and prepare a right strategy in client’s journey towards quality engineering. You will be pivotal to understand the use cases/problems and discovery of the overall testing solution and guide/transition to teams on project processes and deliverables. As a thoughtful and innovative leader, you will be the key advisor in transforming and QA modernization efforts by participating actively in solution architecture, design, development, and testing reviews. You will also anchor business pursuit initiatives, client training and in-house capability building. You will have the opportunity to shape value-adding consulting solutions that enable our clients to meet the changing needs of the global landscape.

Location for this position is in Singapore. This position may require 10% travel.

Skills /Competencies:

• 15+ years’ experience in leading the engagement effort for Medium/ High complexity assignments of Process & Automation led consulting.

• 5+ years’ experience in conducting testing organization assessments, making QE recommendations, and setting up QE organization.

• 5+ years’ experience in leading transformation initiatives across major programs and enterprise QA team.

• Implement, review and guide teams on project processes and deliverables; lead proposal development and anchor large pursuits.

• 2+ years’ experience in new testing offerings like Low code No code tools, AI/ML tools, Meta verse, Sustainability etc

• Contribute to organization branding via thought leadership, client training and in-house capability building.

• Lead and participate in client engagements on one or more of Infosys’s Test Consulting service offerings which includes, Agile DevOps, Program Test Strategy Definition or Technology QA Consulting (Ex: Extreme Automation, Data Services, Test Infrastructure, and tools etc.,).

• Strong Experience in Agile practices and Shift Left practices.

• Should have familiarity with DevOps, CT processes and In-sprint automation.

• Client and business acumen, influencing/negotiating skills with client/product vendors and external stakeholders, cultural affinity.

• Experience in working in onshore/offshore model, agile in adopting customer work culture, mentor & build team.

• Excellent communication & customer interfacing skills

Nice to have

• Consulting anchor who can ensure high quality standards & strive for customer delight.

• Experience in Program management and Stakeholder management

• Experience in cloud full stack development, architecture, design, integration, migration, testing and deploy functions.

• Lead client discussions to improve cloud initiatives and transformations.

• Has knowledge in KPI driven metrics and standards.

• Understand digital disruptive technologies like DevOps, Containers, Microservices, AI/ML, API/Automation, Big Data, Analytics/Data Science, IoT, Blockchain and open-source framework

• IT cloud certifications like CompTIA Cloud+, CCSP, AWS, Microsoft Azure, Google Cloud, CISCO CCNA/CCNP, agile & other test competencies

The job also entails sitting as well as working at a computer for extended periods of time. Should be able to communicate by telephone, email or face to face.

Qualifications

• Bachelor’s degree or foreign equivalent from an accredited institution required.

• At least 15 years of experience with Information Technology in end-to-end test delivery and consulting.

Infosys is an equal opportunity employer and positively encourages applications from suitably qualified and eligible candidates regardless of gender or other attribute covered by equal opportunity legislation. Please note in order to protect the interest of all parties involved in the recruitment process, Infosys does not accept any unsolicited resumes from third party vendors. In the absence of a signed agreement any submission will be deemed as non-binding and Infosys explicitly reserves the right to pursue and hire the submitted profile. All recruitment activity must be coordinated through the Talent Acquisition department.

All aspects of employment at Infosys are based on merit, competence and performance. We are committed to embracing diversity and creating an inclusive environment for all employees. Infosys is proud to be an equal opportunity employer.

• Proven working experience in test delivery or equivalent role with at least 10 years relevant experience in large and complex organisations preferably in the area of Banking and Finance
• Extensive experience in managing end to end delivery of testing services from multiple vendor test service providers
• Proven experience in testing standards, tools, processes & methodologies, frameworks, and various delivery methodologies e.g. Agile, Hybrid Agile and Waterfall, DevOps
• Proven, successful track record of managing shared IT service development and/ or IT Testing Services
• Demonstrated success in developing highly effective working relationships with internal and external stakeholders to deliver collaboration, partnerships and services
• Strong domain knowledge of SAP system and modules like AP, MM, FM and GL. Coordinate closely with SAP functional and technical team to validate system functionality.
• Strong attention to details, excellent analytical and problem solving skills
• Experience in managing multiple external testing service providers
• Experience in managing multi-cultural, diverse, direct and virtual teams.
• Experience in various testing tool suites like HP UFT/QTP, Loadrunner/Performance Center/Sitescope, HP ALM / Quality Center, Tosca, Selenium, JIRA etc.
• Must display a high level of professional judgment, commitment, integrity, and teamwork.
• Excellent client facing, internal communications, written and verbal communication skills.

Position Summary

The incumbent will be responsible for overall management of the Quality Control (QC) Laboratory services and their related support teams. With extensive knowledge of compliance requirements relating to the QC function together with excellent verbal, written, and interpersonal communication skills the incumbent will need to be action-orientated, agile with respect to change management and a strong leader for the quality culture of the Laboratory and the site to achieve the site Quality Control operational objectives. Key accountabilities include:

• Lead, coach and develop a team of QC Managers, supervisors and their related laboratory teams ensuring that analytical (physical, chemical and microbiological) testing, data review activities and Laboratory equipment and systems on site comply with site Standard Operating Procedures (SOPs) and are performed in a safe and reliable manner to support manufacturing operations at the site and across all shifts.
• Ensure that the quality systems in the Laboratory are continually audited with new requirements implemented and all QC related operations comply with Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards (PQS).
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

Responsibilities:

• Responsible for developing and managing integrated Quality Systems and providing technical support and advice on Quality Control matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Development.
• Responsibility of setting up and implementing QC Laboratory quality systems and strategies for developing and implementing monitoring systems to collect, collate and present information on Quality Control Laboratory for performance management and bench marking. This includes review and approval of Standard Operating Procedures (SOPs) and periodic review processes.
• Responsibility for QC personnel management, QC project management, and ensuring that quality risks associated with the QC Laboratory operations are correctly assessed, identified and managed.
• Plan and track Quality Control objectives, timelines, priorities, and resources.
• Develop, write and present business cases for equipment, staff resources and service developments.
• Manage and ensure the provision of chemical and microbiological analytical services to internal/external customers to ensure that all starting materials/water samples/intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements so as to provide accurate test results for correct GMP usage decisions.
• Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
• Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. Perform investigation related to EHS (as needed).
• Ensure that the laboratory equipment are qualified to meet regulatory standards, well maintained and in good working order.
• Work closely with the relevant process owners (i.e. Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting material sources.
• Manage and provide oversight of the strategy and execution of Analytical Method Transfer Exercise (AMTE) from other Pfizer sites and Centre functions for new products introduced to the site. This involves the development / validation / verfication of new /existing analytical methods for testing starting materials, process intermediates, APIs and plant cleaning samples.
• Lead and/or contribute to the implementation of the site and corporate projects in line with specifications and budget allocation.
• Promote use of Right First Time (RFT) methodologies and root cause analysis tools for analytical trouble shooting, safety and Continuous Improvement Projects (CIP). Using Statistical Process Control (SPC) methodologies for improving efficiencies and cost.
• Ensure the product stability programs are managed and testing data (including stability data) is reported for Annual Product Review Reports (APRRs) and regulatory filing in a timely manner.
• Ensure laboratory automation is functional at all times and supports laboratory efficiency.
• Support, promote and demonstrate Pfizer Global Supply (PGS) vision, values and leader behaviors.
• Manage, develop, and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.
• Uphold Pfizer's code of conduct and values.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.
• Collaborate with cross-functional teams to drive flawless execution.
• Fulfil requirements of a first line leader (FLL) as described in site procedure that includes (but is not limited to) the below:
• Engage and inspire team on performance expectations and coach the team to meet expectations using Coaching Skills principles
• Effectively monitor the actions of team members. Ensure presence in the GMP work area to observe work activity and practices.
• Be available for direct report(s) for real time escalation of any concerns or support needs
• Be accountable for Good Data Management and Data Integrity understanding and performance of the team
• Be a role model to support a positive compliance culture
• Be vigilant for potential actions or behaviour that could result in breaches of GMP compliance or Data Integrity principles

Job Related Requirements:

• Effective problem solving skills.
• Demonstrated leadership, management and customer service skills.
• Excellent verbal, written and interpersonal communication and presentation skills.
• Demonstrated ability to interact effectively with senior management, auditors and regulators.
• Strong knowledge of analytical chemistry, analytical method validation, instrumentation, laboratory automation and production processes.
• Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories.
• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment, experience in Empower software.
• Knowledge of six sigma, lean labs and standard work practices.
• Possess a can-do / pride to succeed attitude and be a positive influencer/role model.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Education

Bachelor or Master or Ph.D. degree in Science (Chemistry preferred) or Life Sciences relating to Chemistry, Pharmacy, Pharmaceutical Sciences or Microbiology or a related science.

Experience

• Minimum 8-10 years of technical experience in Quality Control within the pharmaceutical, food, chemical or process industries. Additional experience in Quality Assurance is highly desirable.
• Minimum 5 years in a leadership/supervisory position of professional staff previously, or demonstrated capability to successfully lead large teams.
• Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories.
• Experience in an API manufacturing plant is preferred.
• Effectively communicate through written and oral means, demonstrated ability to interact effectively with senior management, auditors and regulators.

The incumbent will have the following core competencies:

• Project Management skills
• Team Leadership skills
• Communication skills
• Analytical skills
• OPEX skills

Responsibilities:

• Understanding the customer's needs and requirements and the quality standards of the production teams.
• Developing ways to improve the manufacturing process to ensure higher-quality goods.
• Supervising inspectors, technicians, and other staff members and providing guidance.
• Ensuring legal obligations are followed and ensuring compliance with regulatory bodies and with health and safety guidelines.
• Maintaining documentation related to various quality systems and ensuring compliance with applicable legislation and regulation.
• Liaise with certification body on all matters relating to audits.
• Any other adhoc duties as assigned from time to time.

Requirements:

• Must possess a Technical/Engineering, Degree, Diploma or related qualifications
• Have a minimum of five years’ experience in heavy metal fabrication - Aluminium and Stainless Steel or related industry.
• Demonstrate strong leadership organizing and communication skills.
• Proficient in written and spoken English and Mandarin
• Required skill (s) : MS Excel, MS Office
• In-depth knowledge of quality control procedures

• Reviewing and revising testing procedures.
• Conducting inspection checks on goods and production processes.
• Performing manual and automated quality checks.
• Ensuring employees adhere to safety and quality regulations.
• Reporting safety and quality infringements to the QA manager.
• Identifying possible areas for improvement in quality control processes.

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Senior Manager- QA Operations & Release
This role is responsible and ensures that operations are in alignment and compliant with global Quality, internal and general GxP requirements. Ensures that raw materials are tested meeting specifications and DS, DP are produced meeting the specifications per the dossier and approved appropriately for release.

He/she has a strong commitment to drive a quality mindset culture, safety, health and environment (SHE) compliance for the site.

Your main responsibilities are :

• Lead and direct the assigned Quality Process
• Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
• Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations
• Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
• Owns policies and procedures of the assigned Quality Process where applicable.
• Partners with global and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
• Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
• Ensures deviations from assigned Quality Process are documented and investigated
• Ensures QA personnel are qualified and trained to perform assigned tasks
• Support technology transfer activities.
• Develops strategies for assigned Quality Process to be fit for purpose, including continuous improvements and ensure a state of inspection readiness
• Supports inspection and audit preparations
• Participates in inspections, audits and Quality Management Review
• Escalates quality and compliance risks to Head of Department, QA
• Supports improvement initiatives, programs and projects of the assigned Quality Process
• Build, maintain and develop a team to support the deliverables of this assigned Quality Process
• Other responsibilities may be assigned by the manager

What you have to offer :

• At least 12 years’ professional working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry.
• Extensive knowledge in Quality Management System concepts and strong understanding of pharmaceutical business and regulatory governance/framework
• Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing
• Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
• High degree of conscientiousness and diligence
• Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
• Self-starter and learning capacity
• Sense of ownership and honesty (proactive handling of errors)
• Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment
• Expectation to be hands on, interactive and display practical leadership
• Good communication skills
• Fluent in written and verbal English

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

We are looking forward receiving your application.

• BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

www.biontech.com

About us

Dyson is a global technology enterprise. We solve the problems others choose to ignore, with surprising new inventions that defy convention and simply work better. We’re driven by progress and thrive on the challenge of relentless improvement. We’re growing fast and our ambition is huge – more categories, more locations and more people. We push the boundaries of what others have defined as possible. Our engineering approach starts with different thinking. Then we continuously refine our ideas – unwilling to compromise and driven by an obsession for finding a better way. Today we employ more than 5,800 people around the world in software engineering, mechanical engineering and science-related roles. Our Energy Storage(ES) team is responsible for new battery technology that will deliver significantly better performance than conventional battery cells.

About the role

The Senior Quality Manager for Cell Process is responsible to managing the quality of all Lithium-ion (Li-ion) cells made for and by Dyson. Reporting to the respective Head of Quality, this role is responsible in ensuring delivery of safe and reliable battery cells into consumers’ hands. This role requires active engagement with Design, Engineering, Operations and Commercial teams for both products under development and those that have started production. The role includes supporting and assuring our Li-ion cells conform to our exacting quality standards. Extensive knowledge and experience of Li-ion cell production and associated critical-to quality activity is an essential part of this role.

• Lead a cross functional team developing and optimizing the cell manufacturing processes for the next generation cell technology incorporating best practices.
• Lead prototype and pilot builds from the quality perspective through the development of the processes, tooling, and equipment.
• Involvement in design, construction and plant installation for a successful launch, and subsequently continuous improvement of processes and equipment for the production of high-quality cell.
• Ensure design takes into account manufacturing capability and ensure key characteristics are properly cascaded from product characteristics to process characteristics.
• Work with the product design team to integrate new cell design into the production by adjusting or updating equipment and tooling.
• Technically support pilot line troubleshooting and problem-solving.
• Provide inputs to and assure both design of product and process have PFMEA and Fault Tree embedded to drive robustness of processes. Use insights to optimize production design and ensure knowledge documents are created.
• Provide technical direction and support to the project team and suppliers.
• Develop control plan, SOP, and other process documentation and provide required trainings for the production quality teams.
• Review and report cell quality indicators (Key process indicators in processes such as mixing, electrode coating, cell assembly, formation, etc.) and evaluate potential improvements and corrective actions to address any issues that arises.
• Develop production quality metrics.
• Analyse and identify critical processes that affect the safety and reliability of the assembly and ensure there is effective surveillance of the key indicators to assure the quality of the cells being made. In some cases, active surveillance will be required.
• Incorporate Quality into shop floor management systems/ Enterprise Resource Planning system to ensure compliance.
• Facilitate the development of Standard Operating Procedures and documentation required for production operations.
• When needed, provide evidence-based risk assessments for issues and decisions.
• Ensure production maintains manufacturing processes that meet Dyson’s design standards and have a robust Quality System in place, with rigorous controls for critical-to-quality items.
• Provide day to day support and work closely with battery manufacturers and pack assemblers to investigate issues in production and implement corrective actions to minimize yield losses, thus minimizing risk of latent failures.
• Facilitate Dyson Part Approval Process (DPAP).
• Assume other duties as assigned.

About you

• Proven experience in managing a team to set up equipment and process for pilot or production scale cell manufacturing.
• Preferably 10 years of battery experience in cell manufacturing, preferably in Lithium-ion systems.
• B.S. in Mechanical Engineering, Materials Science, Chemical Engineering, or related field. Commensurate relevant work experience will be needed.
• Successful candidates will have meticulous attention to detail, possess outstanding problem-solving skills, and have direct, hands-on machine experience.
• Strong written, verbal, presentation and organizational skills as well as the ability to work and manage time independently.
• Confident to influence and present to senior positions in the company.
• Extensive experience in Quality and/or Engineering Function in the Manufacturing of Lithium-ion (Li-ion) Cells and Battery Pack Assemblies.
• Experienced practitioner of relevant tools and methodologies, such as: FMEAs, Statistical Process Control, 8Ds, 6Sigma certifications, Cost of Quality, Project Management, TQM etc.
• Sound knowledge in ISO 9001/IATF 16949/ VDA6.3.
• <10% travel required.

Benefits

Dyson Singapore monitors the market to ensure competitive salaries and bonuses. Beyond that, you’ll enjoy a transport allowance and comprehensive medical care and insurance. But financial benefits are just the start of a Dyson career. Professional growth, leadership development and new opportunities abound, driven by regular reviews and dynamic workshops. And with a vibrant culture, the latest devices and a relaxed dress code reflecting our engineering spirit, it’s an exciting team environment geared to fuelling and realising ambition.