工作职责:
1. Support Commercial QA Office Head
2. Supervise and Train GMP staff (when staff is added)
3. Perform QA activities of DSCN
★ QA for Imported FDP
★QA for Imported BDP
★ CMO management(Deviation, Change control, Improve quality issues, Maintain QA agreement,
Enhance DI)
★ MAH Product release when delegated
★Market delivery release
★ Enhance Quality Management System in DSCN / DSSH
★GMP Audit
4. Document Control including SOP
5. Contact with Authority
6. Support / Capture DSSH-QA activities
7.Report GMP-QA activities to Commercial QA Head
岗位要求:
1.Bachelor degree or higher in Pharmaceutical or related science categories
2.GMP operation or GMP QA activity, Quality Management (5 years)
3.Chinese, English,(preferred a certain JP)