|1.Perform review of GMP related documents (formulation/synthesis batch records, analytical record, etc.) to ensure batch release timely. |
2. Recognize complex deficiencies in GMP documents, report them to QA&QC manager, chemist or supervisor, suggest actions and supervise agreed follow-up. Propose and survey implementation of agreed preventive actions.
3. Manage and oversee stability study.
4. Manage and oversee the entry, maintenance, and closure of CAPA.
5. Timely write and complete GMP relevant documents in own area: e.g. CoA, stability tests protocol/report, APRs/PQRs, etc.
6. Conduct on-site QA inspection for synthesis/formulation production and line clearance check, label printing confirmation, packing check etc.
- Fluent in English and Chinese (both written and spoken).