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)