QC Chemist (Validation/ Testing/ GMP)

Job Responsibilities

1. Perform analytical and basic microbiological testing accurately and efficiently in accordance with Standard Operating Procedures (SOPs).
2. Perform equipment verification and calibration in accordance with procedures.
3. Document all results in accordance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
4. Ensure all quality records are attached and/or filed as predetermined.
5. Perform quality review of completed test records, approval of QC samples/lot disposition in the Laboratory Information Management System (LIMS), and release of immediates, raw materials, solvents, and packaging materials.
6. Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
7. Perform maintenance and troubleshooting of laboratory equipment as required.
8. Perform equipment qualification and analytical method validation as required.
9. Perform basic microbiological testing such as endotoxin level in water and products.
10. Participate actively and contribute to site project teams.
11. Train fellow colleagues on written procedures and SOPs pertaining to equipment operation, analytical and microbiological test methods, and general laboratory operation.
12. Perform review and approval of test results in the Laboratory Information Management System (LIMS).
13. Perform proactive trending of analytical and microbiological test results.
14. Prepare analytical and microbiological data for Annual Product Review Reports (APRR).
15. Advise on the significance of test results and follow up with appropriate courses of action.
16. Actively participate in Safety initiatives, typically acting as a role model for other analysts.
17. Participate in 5S team initiatives and practice good housekeeping.
18. Lead and conduct laboratory investigations/incidents such as out of specification investigations and equipment troubleshooting investigations, identify root causes, and implement appropriate corrective actions and preventive measures.
19. Participate in Analytical Method Transfer Exercises and independently resolve issues associated with test methods.
20. Develop and validate test methods as required.
21. Lead and manage laboratory equipment validation projects independently.
22. Review test reports and ensure that all laboratory documents are in a constant state of regulatory compliance and inspection readiness.
23. Develop test methods or instrument Standard Operating Procedures (SOPs), write and update Quality Procedures.
24. Plan and deliver technical training to colleagues and develop and review training materials as required.
25. Close coordination with cross-functional colleagues/vendors to achieve desired outcomes (e.g., lab equipment installation/validation/service contract/external contract lab testing fulfillment).

Minimum Requirements

1. Bachelor's Degree.
2. Comprehensive knowledge of cGMPs and appropriate regulations.
3. Comprehensive knowledge of LIMS, HPLC, GC, and laboratory equipment.
4. Demonstrated technical skills in method validation and testing.
5. Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations.
6. Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.

For inquiries, please contact Veronica Neo Shen Hwa: veronica.neo@manpower.com.sg

Personnel Reg No: R1110855

Manpower Staffing Services (S) Pte Ltd

EA Licence No: 02C3423