- Establish and maintain quality control management system and ensure its compliance to cGMP and international regulations (e.g. 21CFR Part 211, EU GMP, China GMP, ICH).
- Review or approve specification and test method of component and drug product and ensure analyst understand their requirements and implement their analysis according to effective method.
- Review or approve protocol or report of method transfer, method verification or method validation to make sure test method is verified or validated before use.
- Review or approve drug product stability study protocol, time point report and final report, identify potential atypical trend if applicable and work with other function (e.g. QA and Production Dept.) if necessary for investigation and root cause determination.
- Participate in material supplier/contract laboratory due diligence, trial study and qualification evaluation.
- Ensure all instrument in laboratory is qualified or calibrated before use.
- Participate in utility qualification, process validation or cleaning validation/verification and make sure lab can support all required test activities according to protocol.
- Responsible for laboratory OOS, OOT and atypical data investigation and make sure root cause is identified, quality impact is thoroughly evaluated and relevant CAPA(s) is prepared for continuous improvement.
- 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.
- Review or approve computerized system validation protocol and make sure system is validated before use and CS validation is compliant to cGMP requirement.
- Establish data integrity management program and ensure integrity of all test data (paper or electronic) and documentation.
- Responsible for utility system (e.g. purified water/HEPA) routine monitoring and work with EG dept. to make sure class D environment is maintained and systems are in qualified status.
- Responsible for instrument requalification program and computerized system periodic review program to make sure equipment and system is maintained in qualified or validated status.
- Responsible for QC staff’s daily work assignment, training/coaching and performance management.
- Coordinate all GMP activities, including but not limited to
Material and drug product test schedule
Test activities in outsourced contract laboratory/Service provider
Stability study schedule
- Responsible for other duties assigned by supervisor.
- Bachelor degree or above with major of Chemistry, science in pharmacy or relevant
- At least 10 years’ working experiences in QC area of drug product manufacturing site(MNC dry product manufacturing site is preferred)
- Solid GMP knowledge of cGMP of US, EU and China
- Good technical skills of quality control in pharmaceutical industry
- Strong capability of leadership and strategic thinking
- Good communication and negotiation skill
- Fluent oral English and Good written English