Job description:
1. Assist the quality head in maintaining and building the GMP system of the plant, including updating and reviewing relevant SOPs and quality manuals to ensure compliance with GMP requirements.
2. Be familiar with relevant drug laws and regulations, track regulatory updates, and require internal SOP updates to maintain GMP compliance.
3. Responsible for change control and impact assessment associated with analytical and testing processes, deviation investigation management, and CAPA tracking.
4. Assist in project management, including technology transfer, CDMO oversight, batch record review, product release review, etc.
5. Communicate with department superiors in a timely manner when issues are identified, especially those affecting production, product quality, and compliance. Ensure deviation investigations are resolved thoroughly, completely, and in a timely manner.
6. Review of QC routine testing data, including audit trail review of electronic data; investigation and review of OOS/OOT/OOE results.
7. Apply scientific knowledge to analyze and solve problems.