1. Establish and/or maintain quality control management system and ensure it is compliance to cGMP and international regulations (e.g. 21CFR Part 11&210&***, EU GMP, China GMP, ICH).
2. Review or approve specification and test method of raw material, component, intermediate and drug product and ensure analyst understand their requirements and implement their analysis according to effective one.
3. Review or approve protocol or report of method transfer, method verification or validation to make sure test method is verified or validated before use.
4. Review or approve drug product stability study protocol, time point report and final report, identify potential atypical trend if applicable and work with other functions (e.g. QA and Production Dept.) if necessary for root cause investigation.
5. Participate in material supplier/contract laboratory due diligence, trial study and qualification evaluation.
6. Ensure analytical instrument in laboratory is qualified or calibrated before use.
7. Participate in utility qualification, process validation or cleaning validation/verification and make sure lab can support all required test activities according to protocol.
8. Responsible for laboratory OOS, OOT and AD (atypical data) investigation and make sure root cause is identified, quality impact is thoroughly evaluated and relevant CAPA(s) is prepared for continuous improvement.
9. Review or approve change control in laboratory area, well assess its impact and prepare implementation step(s) to execute change and minimize or mitigate potential risk.
10. Review or approve computerized system validation protocol and make sure system is validated according to cGMP and best practice requirements (e.g. ISPE GAMP 5) before use.
11. Establish data integrity management program and ensure integrity of all test data (paper or electronic) and record.
12. Responsible for utility systems (e.g. purified water/HEPA) routine monitoring and work with EG dept. to make sure class C/D environment is maintained and systems are in qualified status.
13. Responsible for instrument lifecycle management (e.g. requalification program and computerized system periodic review program) to make sure instrument and related system is maintained in a qualified or validated status.
14. Responsible for QC staff’s daily duty assignment, training/coaching and performance management.
15. Coordinate all GMP activities, including but not limited to
Reference standard management
Material and drug product test schedule
Test activities in outsourced contract laboratory/Service provider
Stability study schedule
16. Responsible for other duties assigned by supervisor
1. Bachelor degree or above with major of Chemistry, science in pharmacy or relevant
2. At least 10 years’ working experiences in QC area of pharmaceutical manufacturing site (MNC working experience is preferred)
3. Solid GMP knowledge of current cGMP of US, EU and China.
4. Good technical skills of quality control in pharmaceutical industry
5. Strong capability of leadership and strategic thinking
6. Good communication and negotiation skills
7. Fluent oral English and Good written English