1. Perform analytical equipment lifecycle management as per current regulatory requirements / SOP.
2. Involve in equipment qualification, writing URS, reporting and implementing SOP’s for system operation and maintenance, monitoring performance of the equipment and decommissioning of equipment.
3. Support and / or perform maintenance / calibration of laboratory equipment in compliance with established schedules.
4. Liaise with vendors/service providers for PM / Calibration in a timely manner.
5. Responsible for maintenance / calibration planning of equipment within QC Department.
6. Ensure real time documentation, maintain data integrity and appropriate traceability.
7. Responsible for the accurate, timely and compliant execution of assigned projects and related documentation.
8. Assist / perform method validation and transfer as required.
9. Conduct QC Department equipment operation and maintenance training to QC staff as required.
10. Perform and / or support in maintaining the asset register for equipment in the QC Department.
11. Initiate CAPEX for equipment purchase.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Any other activities as and when assigned by the Superior.

EDUCATION & EXPERIENCE

EDUCATION: Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biotechnology).

EXPERIENCE: Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.

KNOWLEDGE & SKILLS

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. A good team player with positive learning attitude.
3. Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Excellent interpersonal and analytical skills, good verbal and written communication skills.

• samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
• Preparation of reagents/diluents/ dissolution media as per STP.
• Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
• Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
• Assist in maintenance and calibration of test instruments per specifications.
• Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
• Knowledge of analytical chemistry, chromatography (HPLC/GC) and drug dissolution testing.
• Familiar with LIMS, and reporting of any observed results that do not meet the requirement [OOS/OOT/Deviation] for further investigation.
• Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
• Ensure real time documentation.
• Maintain data integrity and appropriate traceability.
• Thorough knowledge and understanding of BP, USP, cGMP and FDA guidelines.
• Maintain a clean and safe work environment and follow safety procedures and policies.
• Create and maintain lab record documentation (notebooks and computer based) per GMPs.

EDUCATION & EXPERIENCE:

• Degree / Diploma in Science related discipline.
• Minimum 2 years of experience in a pharmaceutical environment

Candidates are encouraged to apply this position via email to lincy.lim@pharmagend.com with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background
• Only shortlisted applicants will be notify

Company information

Registration No.

202304645W

Employer questions

Your application will include the following questions:

Which of the following statements best describes your right to work in Singapore?

Which of the following Microsoft Office products are you experienced with?

How much notice are you required to give your current employer?

Which of the following languages are you fluent in?

• Provide IT support services for end users on IT related issues to resolve for software as well as Hardware by troubleshooting or coordinating with vendor support services.
• Knowledge in user profile configuration with required applications.
• Knowledge in hardware like laptops, computers, printer, scanner, and network devices, etc.
• Knowledge in software like Windows OS, office 365 email, share point, antivirus client, VPN and adobe acrobat, etc.
• Ability to Manage servers, storage, network equipment for access management inclusion of Active directory, File Servers etc.
• Ability to manage new IT projects and well coordination with vendor team for delivered on time, within budget, and meeting stakeholder expectations.
• Ability to manage the peripherals requirement planning, purchase initiation and vendor coordination.
• Ability to quickly Comprehensive understanding of QC laboratory standalone connected instruments and Chromleon connected systems for operation of instruments and application.
• Knowledge in backup and restoration process with support of backup applications.
• Any other activities as and when assigned by the Superior.

REQUIREMENT

• Effective communication and interpersonal abilities, including the ability to communicate technical concepts to non-technical stakeholders.
• Bilingual in both English and Mandarin (including read, speak and write).
• A good team player with positive learning attitude.
• Able to work independently with minimum supervision.

EDUCATION & EXPERIENCE

• Minimum Diploma or Degree in computer science, information technology or relevant discipline.
• Preferably with at least 5 years’ relevant experience in IT management, or digital transformation in Pharmaceutical manufacturing industry.

Candidates are encouraged to apply this position via email to lincy.lim@pharmagend.com with the following information in the resume,

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

1. Preparation, execution and review of computer system validation protocols and reports.

2. Preparation and management of CSV deliverables for laboratory instruments and systems, manufacturing equipment, utility systems, IT, and enterprise systems.

3. Ensure the Computer System Validation is in alignment with the Validation Master Plan for Computer Systems.

4. Ensure timely completion of all validation related activities including computer system, equipment, utilities, and facility with compliance.

5. Perform assessment of vendor documents for CSV deliverables.

6. Conduct risk assessments to identify potential risks associated with computerized systems, including data integrity, security, and regulatory compliance.

7. Preparation and review of standard operating procedures to establish and maintain the quality system of the organization.

8. Participate in CFT meeting related to IT systems and ensure the completion of pending actions.

9. Periodic Review of IT application and systems implemented and compilation of reports.

Education and Experience

Diploma or Degree in IT or equivalent.

A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.

Experience in electronic validation system, QMS, ERP system, SCADA, is preferred.

Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.
• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.
• Candidate must have knowledge and experience of qualification/validation principles and their practical application.
• Preparation and review of process and cleaning validation protocols and reports.
• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.
• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.
• Write, review, and revise validation SOPs in compliance with regulatory guidelines.
• QA oversight and/or review during the validation process.
• Manage incidents and deviations related to validation & qualification.
• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.
• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.
• Cross train and develop expertise in other areas of validation.
• Must be able to interact and lead effectively in a team-based environment.
• Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE

• Degree a scientific discipline or equivalent.
• Experience in a regulated industry preferred.
• A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.
• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.
• We regret only shortlisted candidates will be contacted.

KEY DUTIES AND RESPONSIBILITES:

• Providing secretarial and personalized support to both the CEO and President of the company.
• Coordinate with various stakeholders to manage both the CEO and President’s calendar for appointments, meetings, events and functions.
• Take and circulate meeting minutes and ensure follow-up actions in the minutes are carried out.
• Coordinate and make arrangements for both the CEO and President’s travelling trips including but not limited to itinerary planning, flight, hotel, transportation, reservations and meetings.
• To maintain proper record of both the CEO and President’s monthly expenses claims and submit it accordingly.
• Receive and attend to all the CEO and President’s guests.
• Attends to feedbacks from the public and meetup with internal and external stakeholders as when required.
• Prepares newsletters, notifications and letters to circulate to both internal and external stakeholders.
• Handles incoming and outgoing letters from and to relevant authorities pertaining to company feedback and complaints.
• Assist other general administrative support such as filing, preparing reports and correspondence.
• Any other activities as and when assigned by the Superior.

REQUIREMENT

• Minimum Diploma or Degree in Mass Communication.
• Preferably with at least 3 years’ relevant experience in Public Relations and Administration support role.

Candidates are encouraged to apply this position via email to lincy.lim@pharmagend.com with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

KEY DUTIES AND RESPONSIBILITES:

• Chauffeur the CEO and President to and from work and other occasions safely and on time.
• Transporting visitors, business partners and associates as instructed.
• Plan and execute efficient routes to ensure timely arrivals.
• Ensure the cleanliness, hygiene & daily upkeep of the car, including topping up petrol, cash card value.
• Conduct basic maintenance check on vehicle and ensure vehicle is well maintained.
• Run errands and conduct other ad-hoc duties assigned by company.

REQUIREMENTS:

• Possess a valid Class 3 driving license and good driving records.
• Minimum GCE 'O' level, NITEC or Higher NITEC or equivalent.
• Willing to standby and work overtime (with OT pay) when necessary.
• Able to commence work immediately or within short notice.
• Present a professional attitude and handle confidential information according to non-disclosure guidelines.

Candidates are encouraged to apply this position via email to lincy.lim@pharmagend.com with the following information in the resume.

• Work experiences and job responsibilities.
• Current and Expected salary
• Reason for leaving.
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

• Act as point of contact for all EHS related matters.
• Provide over-arching EHS support during project construction.
• Monitor and ensure site operation conforms to statutory requirement.
• Take over as point of contact for liaison with authorities for certification and licensing (E.g. FSSD, NEA, SCDF).
• Provide advice and consultation on safety and health to Engineers to maintain work site in compliance with statutory requirements.
• Implement risk assessment and mitigation measures.
• Provide safety advice to contractors and correcting potential hazards at work.
• Oversee and review all the accident/incident investigations and reports.
• Gather and compile monthly EHS statistics and reports to the Project Manager or designated person as assigned.
• To conduct independent assessment on any incidents / accidents at the site.
• Responsible for coordinating, implementing and monitoring the workplace and environmental health and safety plan of the project.

Requirement:

• Good understanding of safe working practices and cGMP.
• A good team player with positive learning attitude.
• Excellent verbal, written and interpersonal communication skill.
• Ability to work independently to meet assigned schedules.
• Must be registered WSHO with MOM and is a certified FSM.

EDUCATION & EXPERIENCE:

• Min. Diploma with minimum 3 years of experience in pharmaceutical industry (preferred but not a must).
• Experience in developing, implementing and maintaining EHS operations for pharma industry will be an advantage.
• Work at height Training Course for Assessor.
• Able to multi-task and work in a team.
• With certified Occupational First Aider has an added advantage.

Candidates are encouraged to apply this position via email to lincy.lim@pharmagend.com with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary

Company information

Registration No.

202304645W

Employer questions

Your application will include the following questions:

• Which of the following statements best describes your right to work in Singapore?
• How much notice are you required to give your current employer?
• Which of the following languages are you fluent in?

KEY DUTIES AND RESPONSIBILITES:

• Providing secretarial and personalized support to both the CEO and President of the company.
• Coordinate with various stakeholders to manage both the CEO and President’s calendar for appointments, meetings, events and functions.
• Take and circulate meeting minutes and ensure follow-up actions in the minutes are carried out.
• Coordinate and make arrangements for both the CEO and President’s travelling trips including but not limited to itinerary planning, flight, hotel, transportation, reservations and meetings.
• To maintain proper record of both the CEO and President’s monthly expenses claims and submit it accordingly.
• Receive and attend to all the CEO and President’s guests.
• Attends to feedbacks from the public and meetup with internal and external stakeholders as when required.
• Prepares newsletters, notifications and letters to circulate to both internal and external stakeholders.
• Handles incoming and outgoing letters from and to relevant authorities pertaining to company feedback and complaints.
• Assist other general administrative support such as filing, preparing reports and correspondence.
• Any other activities as and when assigned by the Superior.

REQUIREMENT

• Minimum Diploma or Degree in Mass Communication.
• Preferably with at least 3 years’ relevant experience in Public Relations and Administration support role.

Candidates are encouraged to apply this position via email to lincy.lim@pharmagend.com with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

KEY DUTIES AND RESPONSIBILITES:

· Perform various activities and tasks required in the Compression machines.

· Operate all relevant equipment, clean, assemble and maintain the cleanliness of the equipment.

· Perform and maintain the documentation of operations in accordance with cGMP requirement.

· Operate the equipment appropriately in accordance with Standard Operating Procedure / batch document.

· Perform online monitoring of in process parameters / checks throughout the batch.

· Complete all relevant records and other documentation required for packing, maintenance and cleaning of equipment in the work area.

· Perform all activities in accordance with cGMP.

· Maintain the cleanliness of work area to ensure cGMP compliance.

· Perform all other relevant duties required to meet the schedule.

· Check relevant material and product details against batch document.

· Co-ordination with Engineering for break down rectification of Compression equipment.

· Involve in equipment / process qualification.

· Participate in investigation of process deviation, cGMP and all other compliance related matters, where applicable.

· Ensure compliance to GxP / Safety / Quality policies.

REQUIREMENT

· Good understanding of safe working practices and cGMP.

· Experience in tablet compression machine or related tableting press.

· A good team player with positive learning attitude.

· Willing to work in Tuas area, in cleanroom environment with full gowning.

EDUCATION & EXPERIENCE

· Minimum GCE 'O' level or NITEC or Higher NITEC or Diploma in Biotechnology / Biomedical / Mechanical / Mechatronics Engineering or relevant disciplines

· With 2-5 years of manufacturing experience in Pharmaceutical or related industries.

· Entry level NITEC / Higher NITEC / Diploma candidates are welcome to apply.

• Provide IT support services for end users on IT related issues to resolve for software as well as Hardware by troubleshooting or coordinating with vendor support services.
• Knowledge in user profile configuration with required applications.
• Knowledge in hardware like laptops, computers, printer, scanner, and network devices, etc.
• Knowledge in software like Windows OS, office 365 email, share point, antivirus client, VPN and adobe acrobat, etc.
• Ability to Manage servers, storage, network equipment for access management inclusion of Active directory, File Servers etc.
• Ability to manage new IT projects and well coordination with vendor team for delivered on time, within budget, and meeting stakeholder expectations.
• Ability to manage the peripherals requirement planning, purchase initiation and vendor coordination.
• Ability to quickly Comprehensive understanding of QC laboratory standalone connected instruments and Chromleon connected systems for operation of instruments and application.
• Knowledge in backup and restoration process with support of backup applications.
• Any other activities as and when assigned by the Superior.

REQUIREMENT

• Effective communication and interpersonal abilities, including the ability to communicate technical concepts to non-technical stakeholders.
• Bilingual in both English and Mandarin (including read, speak and write).
• A good team player with positive learning attitude.
• Able to work independently with minimum supervision.

EDUCATION & EXPERIENCE

• Minimum Diploma or Degree in computer science, information technology or relevant discipline.
• Preferably with at least 5 years’ relevant experience in IT management, or digital transformation in Pharmaceutical manufacturing industry.

Candidates are encouraged to apply this position via email to lincy.lim@pharmagend.com with the following information in the resume,

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

KEY DUTIES AND RESPONSIBILITES:

· Lead a performing Engineering team covering of utilities, facilities, and warehouse for the manufacturing site.

· Achieve financial objectives through efficient utility operation, cost improvement actions and optimal cost options.

· Planning & execution of all new and retrofit projects related to utilities & facilities.

· Ensuring best available technologies are incorporated by design.

· Techno commercial evaluations of consultants, vendors, and contractors.

· Delivering the project within the budget and timeline approved.

· Responsible for relevant project costing and annual budget preparation related to engineering, facilities and EHS.

· Coordinating with statutory authorities for relevant approvals.

· Complying with operational and personnel standards, regulatory and statutory requirement to ensure efficient, reliable, and uninterrupted operation.

· Ensure smooth handing over of the project to end-users, coordinate and ensure deliverables as per plan.

· Ensure the site's facilities are kept to the highest standards for cGMP requirements, including Purified water system, HVAC system, EMS, BMS, Boilers, fire safety, security, pest control, cleaning services and waste removal.

· Responsible for utilities & Facilities equipment Operation, Maintenance, Calibration, spares management and drawings management.

· Responsible for development SOPs and quality standard for site with following of site QMS procedures.

· Ensure to meet required the regulatory requirements (e.g. HSA, FDA etc.) and keep site audit ready for all the time.

· Responsible for managing a team of vendors / contractors.

· To assist on any ah-hoc duties that been assigned / task by the immediate superior

REQUIREMENT

Hard Skills:

· To possess knowledge in either pharmaceutical utilities (Purified water, compressed air, technical gases, HVAC, etc) or process equipment (Compression, granulators, coaters, etc)

· Possess intermediate to advanced knowledge in a core engineering discipline, esp. in cleanroom environment.

Soft Skills:

· Leadership

· Critical thinking

· Able to work in a team

· Self-motivated

EDUCATION & EXPERIENCE

· Degree or Diploma in Mechanical/ Electrical/ Electronics/ Chemical Engineering

· Minimum 5 years for Degree holders or 8 years for Diploma holders (Candidates with prior experience in a GMP environment will be preferred)

1. Preparation, execution and review of computer system validation protocols and reports.

2. Preparation and management of CSV deliverables for laboratory instruments and systems, manufacturing equipment, utility systems, IT, and enterprise systems.

3. Ensure the Computer System Validation is in alignment with the Validation Master Plan for Computer Systems.

4. Ensure timely completion of all validation related activities including computer system, equipment, utilities, and facility with compliance.

5. Perform assessment of vendor documents for CSV deliverables.

6. Conduct risk assessments to identify potential risks associated with computerized systems, including data integrity, security, and regulatory compliance.

7. Preparation and review of standard operating procedures to establish and maintain the quality system of the organization.

8. Participate in CFT meeting related to IT systems and ensure the completion of pending actions.

9. Periodic Review of IT application and systems implemented and compilation of reports.

Education and Experience

Diploma or Degree in IT or equivalent.

A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.

Experience in electronic validation system, QMS, ERP system, SCADA, is preferred.

Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

1. Perform analytical equipment lifecycle management as per current regulatory requirements / SOP.
2. Involve in equipment qualification, writing URS, reporting and implementing SOP’s for system operation and maintenance, monitoring performance of the equipment and decommissioning of equipment.
3. Support and / or perform maintenance / calibration of laboratory equipment in compliance with established schedules.
4. Liaise with vendors/service providers for PM / Calibration in a timely manner.
5. Responsible for maintenance / calibration planning of equipment within QC Department.
6. Ensure real time documentation, maintain data integrity and appropriate traceability.
7. Responsible for the accurate, timely and compliant execution of assigned projects and related documentation.
8. Assist / perform method validation and transfer as required.
9. Conduct QC Department equipment operation and maintenance training to QC staff as required.
10. Perform and / or support in maintaining the asset register for equipment in the QC Department.
11. Initiate CAPEX for equipment purchase.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Any other activities as and when assigned by the Superior.

EDUCATION & EXPERIENCE

EDUCATION: Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biotechnology).

EXPERIENCE: Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.

KNOWLEDGE & SKILLS

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. A good team player with positive learning attitude.
3. Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Excellent interpersonal and analytical skills, good verbal and written communication skills.

• Act as point of contact for all EHS related matters.
• Provide over-arching EHS support during project construction.
• Monitor and ensure site operation conforms to statutory requirement.
• Take over as point of contact for liaison with authorities for certification and licensing (E.g. FSSD, NEA, SCDF).
• Provide advice and consultation on safety and health to Engineers to maintain work site in compliance with statutory requirements.
• Implement risk assessment and mitigation measures.
• Provide safety advice to contractors and correcting potential hazards at work.
• Oversee and review all the accident/incident investigations and reports.
• Gather and compile monthly EHS statistics and reports to the Project Manager or designated person as assigned.
• To conduct independent assessment on any incidents / accidents at the site.
• Responsible for coordinating, implementing and monitoring the workplace and environmental health and safety plan of the project.

Requirement:

• Good understanding of safe working practices and cGMP.
• A good team player with positive learning attitude.
• Excellent verbal, written and interpersonal communication skill.
• Ability to work independently to meet assigned schedules.
• Must be registered WSHO with MOM and is a certified FSM.

EDUCATION & EXPERIENCE:

• Min. Diploma with minimum 3 years of experience in pharmaceutical industry (preferred but not a must).
• Experience in developing, implementing and maintaining EHS operations for pharma industry will be an advantage.
• Work at height Training Course for Assessor.
• Able to multi-task and work in a team.
• With certified Occupational First Aider has an added advantage.

Candidates are encouraged to apply this position via email to lincy.lim@pharmagend.com with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary

Company information

Registration No.

202304645W

Employer questions

Your application will include the following questions:

• Which of the following statements best describes your right to work in Singapore?
• How much notice are you required to give your current employer?
• Which of the following languages are you fluent in?