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Job Responsibilities:
1. New product registration:
Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists.
Compile/ review/check material for dossier prior to submission, incorporate feedback from relevant stakeholders.
Conduct checks on artworks to ensure in compliance with local regulation.
2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.
3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.
4. Update and maintain database of regulatory and product registration information.
5. Good maintenance of final submitted documentation and local repository.
6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.
7. Support any audits or inspections.
8. Guide/ oversee work performance and development of direct report.
9. Provide input for periodic operation metrics/ budget initiatives by managing operating expenses within approved budget for the year.
10. Handle any other assingment as advised by supervisor.
Requirements:
Perks & Benefits
TIGER BALM (M) SDN BHD is an established company that manufactures markets and distributes high quality OTC pharmaceutical product. Nearly 100 years ago, a Chinese herbalist prepared an effective, fast-acting balm under a secret formula with all natural ingredients. One of its Tiger Balm is a brand leader in many overseas markets and is famous around the worlds.The production base moved from Burma to Singapore in 1926. From here the product was aggressively marketed and sold into many neighbouring countries. Today, Tiger Balm is world famous being sold in over 100 countries in 5 continents. Why join us? Attractive remuneration package. Excellence career advancement opportunity. Good learning environment We advocate safe working environment for all our employees.
工作職責:
1、新產品註冊:
根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。
在提交之前編譯/審查/檢查檔案資料,納入相關利害關係人的回饋。
對藝術品進行檢查,以確保符合當地法規。
2. 遵守監管要求:透過及時變更和/或更新來維持現有許可證/認證/授權(例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證)的有效性,以確保供應連續性。
3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。
4.更新和維護監管和產品註冊資訊資料庫。
5. 妥善維護最終提交的文件和本機儲存庫。
6. 確保遵守監管事務、行政維護規定的品質程序,並規劃/建議營運改善。
7. 支持任何審計或檢查。
8. 指導/監督工作績效和直接報告的發展。
9. 透過在年度核准的預算內管理營運費用,為定期營運指標/預算計畫提供輸入。
10. 處理主管建議的任何其他分配。
要求:
津貼和福利
TIGER BALM (M) SDN BHD is an established company that manufactures markets and distributes high quality OTC pharmaceutical product. Nearly 100 years ago, a Chinese herbalist prepared an effective, fast-acting balm under a secret formula with all natural ingredients. One of its Tiger Balm is a brand leader in many overseas markets and is famous around the worlds.The production base moved from Burma to Singapore in 1926. From here the product was aggressively marketed and sold into many neighbouring countries. Today, Tiger Balm is world famous being sold in over 100 countries in 5 continents. Why join us? Attractive remuneration package. Excellence career advancement opportunity. Good learning environment We advocate safe working environment for all our employees.
Job Description
What you will do:
Key responsibilities include:
Requirements:
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Job Description and Requirements
The Web QA Manager is responsible for the vision, direction, leadership and administration of RBFCU’s QA team. Helps develop short and long-term strategies to enhance QA practices and methodologies. Develops and implements quality assurance problem reporting processes and systems. The Web QA Manager ensures software adheres to requirements and functional specifications via application of automated and manual software testing methodologies. Leads a team of QA analysts to execute software testing patterns for multiple software programs, as well as coordinate User Acceptance Testing. Provide leadership in building effective relationships with external/Internal business stakeholders and identify technology for consideration while ensuring that RBFCU web properties are developed and maintained in a way provides the highest quality product and an efficient and cost-effective workflow.
Essential Functions and Responsibilities
Oversee the design, development and implementation of QA assets (Manual and Automation) for organizational enterprise information systems, software and mobile application.
Participates in multiple projects and oversees staff to ensure that specifications are met on time and within budget. Demonstrated commitment to quality and the process of continuous improvement.
Develop strong relationships with coworkers, and mentor/guide lead QAs and team.
Evaluate/increase QA effectiveness; Advise, counsel and educate on competitive or financial impact.
Have a passion for learning and staying updated on emerging trends and technologies.
Manage the Web QA team and oversee concurrent, high-quality timely QA of mission-critical applications and technology to support the RBFCU digital goals.
Create QA plan and manage execution of all testing deliverables and adherence to milestones.
Oversee and manage the design and execution of test strategies, plans and cases.
Validation of program and project testing approaches proposed by manage services partners and vendors.
Ensure testing approach is communicated and signed off by all project leads.
Ensure adequate coverage of the requirements and business processes are incorporated in the testing approach.
Analysis of requirements and design solutions.
Defect management and issue resolution through all phases of testing.
Manage and effectively communication issues and progress to peers, IT Management and manage service partners.
Oversees projects requiring coordination between various IT, business and external vendors.
Educate development and business areas on the IT quality assurance process and deliverables.
Generate daily status and metrics to leadership, business resources and project team members.
Create test strategies and plans for technical initiatives.
Oversee and manage testing effort for multiple projects.
Deliver crucial conversations associated with testing risk and issues to project leadership and IT management with proposed resolution.
Identify project risk and issues in a timely non-confrontational manner.
Expertise in risk-based analysis.
Work with end users in the planning and coordination of UAT effort.
Sound knowledge of Manual, Automated, Performance, Database, Web, Mobile app testing concepts and methodologies.
Knowledge in business requirement gathering, API and security testing will be preferred.
All other duties as assigned (note: essential functions and responsibilities may change or new ones may be assigned at any time with or without notice).
Requirement
Bachelor's Degree in a related field of study
Minimum 3 years experience managing QAs and extensive hands-on experience of different types of testing and methodologies- Manual, Automated, Performance, Database, Web, Mobile app testing
Experience in Financial domain and working knowledge of Core Banking Application
Experience in gathering and maintaining the business requirements for the new enhancements and change requests
Create and execute manual and automated tests based on feature enhancements for Web application and Mobile app
Experience in testing the Mobile App on iOS and Android platforms
Proficient in writing SQL queries to validate the end-to-end testing scenarios
Working knowledge of one or more key Web and mobile applications technologies
Strong leadership and management skills as well as project management skills
In-depth knowledge of QA procedures, principles and tools
Experience in leading QA Leads and resources
Excellent communication and presentation skills, with a strong ability to communicate business and technical information
Ability to develop strong working relationships with customers, peers, and IT leadership
Excellent management skills and the ability to organize and plan effectively to meet both short and long- term goals and objectives
Skills and/or Certifications/Licensing
Web and Mobile app testing (Manual and Automated)
Database, Security, performance and regression testing
Experience in any defect management tool - Jira is preferred
Experience in any test management tool
Proficient in writing SQL queries to validate the end to end testing scenarios
Experience with test frameworks such as TestNG, JUnit, Jasmine etc.
Proficiency in one or more of the following technologies: Cypress with Typescript, Selenium Webdriver automation with Java, Python or other object-oriented languages
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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The Area: The Information Security department is responsible for setting enterprise security policies and standards that are designed to protect the confidentiality, integrity and availability of Morningstar information. The security team offers guidance and technical expertise in areas like application security, policies and procedures, disaster recovery and compliance/regulation. We analyze emerging security threats and conduct risk and vulnerability assessments to ensure that our information remains secure.
The Role: The Information Security Team is looking for a Lead IT Compliance Analyst to join the IT Compliance Team. The Lead IT Compliance Analyst will help support Morningstar Information Security’s compliance responsibilities around regulatory compliance and PCI DSS. This individual will help Morningstar meet current and future compliance obligations, assist in identifying and following up on information security findings, gather evidence required for internal and external regulatory audits. This position is based in our Toronto office.
Responsibilities:
Requirements:
Nice To Have:
100_MstarResCanad Morningstar Research, Inc. (Canada) Legal Entity
Morningstar’s hybrid work environment gives you the opportunity to work remotely and collaborate in-person each week. We’ve found that we’re at our best when we’re purposely together on a regular basis, at least three days each week. A range of other benefits are also available to enhance flexibility as needs change. No matter where you are, you’ll have tools and resources to engage meaningfully with your global colleagues.
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CLIENT: Energy trading firm
COVERAGE: Regional
SUMMARY
Oversee the control activities across the region and to ensure that our control framework is governing our business operation in a safe and compliant manner.
Identify weaknesses within the organization's IT processes and infrastructures and ensure that proper measures are implemented to minimize such risk. Ensure that an optimised set of business process maps are in place and our internal procedures are promptly updated to reflect the agreed framework.
Work closely with both commercial and functional teams, to provide solutions/ recommendations to improve the controls and drive efficiency through continuous improvement. Proactively look out for any breach of procedure by our staff and potential control gap that could create a material risk to our organisation.
Responsible for collating global Internal Control reporting information that is required by both internal management and external stakeholders.
THE ROLE
Ensure an appropriate and tailored IT risk framework is in place and aligned with the overall IC framework;
Proactively identify IT control gaps and work closely with IT team on the risk mitigations plan and documentation
Conduct reviews on the privilege ID usage, ETRM and Finance systems’ user access rights to ensure adherence to access controls standards
Provide support on IT risk and control type of initiatives, including new system implementation and significant system change projects to ensure that proper controls are considered and included at the design-phase
Ensure an optimised set of business process maps is in place and aligned with the system controls;
Lead and conduct IT related control gaps/incidents reviews, including root cause analysis, identification of mitigating controls, follow-up on the remediation actions
Proactively identify control and process improvement initiatives and drive continuous improvement in the organization
Provide internal control guidance and support to commercial and functional teams in managing the operational risks, and ensuring the quality and consistency of the internal procedures from an IC perspective
Coordinate the Operational Sign Off process for all new business activity/product and tracking action items signed off by relevant functions
Perform daily controls monitoring and review
Compile and prepare key risk indicator report on a monthly and ad-hoc basis
Ensuring consistency of IC approach across the whole company
Coordinate and ensure key company policies and procedures are updated annually and are aligned to our Parents’ Internal Control requirements;
Provide assistance to both internal and external audits, including J-Sox reporting, and ensure timely completion of all open actions.
Degree in Computer Science, Information Systems/Security, Business Management or its equivalent, with professional certification in security and controls
Minimum of 5 years relevant industry experience in risk and control management within IT or IT audit
Broad exposure to a range of diverse technology, security concepts, tools, and methodologies
Experienced in reviewing technology domains across infrastructure, applications, cyber security, cloud technology, IT governance processes
Experience in IT incident investigation and reporting
Experience in an energy/commodity trading environment, or related regulatory environment an advantage
Experience in Sarbanes-Oxley/J-Sox reporting preferred
Knowledge of Application Security frameworks and standards
Competent in the full suite of MS Office packages – specifically Word, Excel, Visio PowerPoint applications.
Competency in use of data analytics and visualization tools (e.g. Power BI, Python, SQL, ACL, Alteryx, Tableau) is a considerable advantage.
Knowledge of Allegro, SUN, CubeLogic, ZEMA and IMOS would be an advantage
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JOB DUTIES:
JOB REQUIREMENTS:
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Proud member of the Disability Confident employer scheme
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· Prepares test plans, test cases and test scripts. to test each software component and demonstrate the business condition under test and the expected results.
· Execute regression tests, functional tests and data tests.
· Test environment setup, defects tracking and coordinating with PO, users and tech team to resolve the issues and determine defect priority.
· Estimates work requirement for contribution to the project sprint plan, report and track UAT deliverables.
· Stays abreast of QA & Testing best practice and latest available tools (HP Quality Centre and ALM), frameworks and standards.
· Ensures high Quality and accuracy is maintained through to software release.
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Responsibilities:
We are looking for compliance personnel to assist in enhancing the compliance risk framework of the company. The candidate will help to manage and execute the compliance programs, provide policy guidance and to carry out compliance training for the company’s diversified investment business groups. Depending on the candidate’s experience, duties will include the following:
• Conduct compliance reviews and monitoring/surveillance across the company’s business activities;
• Develop risk-based compliance programs to facilitate the execution of compliance reviews and monitoring;
• Advise the business units in meeting regulatory requirements through implementing appropriate compliance risk policies, assisting with the design and implementation of risk and compliance management initiatives, and enhancing and improving internal processes and procedures;
• Review the completed risk and compliance assessment returns from each area of the business, identifying trends and areas of concern and working with the business units to reduce any unacceptable exposures to regulatory risk;
• Provide compliance training and support through issuing of internal compliance updates, training modules and compliance guidelines
Requirements:
• Minimum 3-5 years’ relevant experience in compliance, audit or risk management in the securities, financial advisory or fund management industry
• Should have knowledge of key applicable regulations in Singapore such as the Securities & Futures Act, Financial Advisers Act, MAS Notices and Guidelines, AML/CFT regulations
• Excellent writing and communication skills
• Good interpersonal, influencing and networking skills
• Team player
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Responsibilities:
We are looking for compliance personnel to assist in enhancing the compliance risk framework of the company. The candidate will help to manage and execute the compliance programs, provide policy guidance and to carry out compliance training for the company’s diversified investment business groups. Depending on the candidate’s experience, duties will include the following:
• Conduct compliance reviews and monitoring/surveillance across the company’s business activities;
• Develop risk-based compliance programs to facilitate the execution of compliance reviews and monitoring;
• Advise the business units in meeting regulatory requirements through implementing appropriate compliance risk policies, assisting with the design and implementation of risk and compliance management initiatives, and enhancing and improving internal processes and procedures;
• Review the completed risk and compliance assessment returns from each area of the business, identifying trends and areas of concern and working with the business units to reduce any unacceptable exposures to regulatory risk;
• Provide compliance training and support through issuing of internal compliance updates, training modules and compliance guidelines
Requirements:
• Minimum 3-5 years’ relevant experience in compliance, audit or risk management in the securities, financial advisory or fund management industry
• Should have knowledge of key applicable regulations in Singapore such as the Securities & Futures Act, Financial Advisers Act, MAS Notices and Guidelines, AML/CFT regulations
• Excellent writing and communication skills
• Good interpersonal, influencing and networking skills
• Team player
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Assistant Manager / Manager, Quality Assurance
About CorDx:
CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.
CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.
With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.
CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Job Responsibilities
Qualifications:
How to Apply:
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· Manage and enforce in-house Quality Management System according to ISO13485 / MDD / MDR/ MDSAP requirements
· Review constantly the effectiveness and relevancy of SOPs, Quality Manual and Technical File
· Report to management team on the performance of the Quality Management System and Quality Improvement Plan
· Work closely with Regulatory Affairs function to develop and manage international product registrations
· Support Clinical, Design Development, Marketing, Business Development and Revenue functions upon request
· Support any non-compliance with respective outsourced third-party service providers and suppliers
· Lead daily operations and incidents arising from manufacturing and quality
· Support the submission of significant change notification and documentation to Notified Body
· Lead periodic key suppliers’ audit and suppliers’ evaluation
· Ensure validity of all suppliers’ certification and agreement
· Keep abreast, identify changes required to meet new standards in an ever-changing regulatory environment
· Manage entire manufacturing process from purchasing to final product release to ensure adequate inventory to fulfil customers’ order
· Take lead roles in ongoing design change and process validation
· Support external and internal audits
· Validate, monitor and measure to ensure related quality KPIs are achieved
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The Role:
My Client is a global fund manager and we are looking for a Compliance Manager for the Singapore office. This is a new headcount in the business with growth potential to take on a regional portfolio within the business. You will be given the autonomy to spearhead new Compliance polices and framework across the region.
Responsibilities:
Requirements:
Take charge of this opportunity to welcome a new career challenge in 2024.
EA Personnel No R1985201
BeathChapman Pte Ltd
Licence No 16S8112
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