职责描述：

1.Following good documentation practice to build up and maintain sustainable quality system, guide and supervise the implementation, to ensure *** logistics center complies with local GDP (GSP) / GMP requirements and global quality standards.

2.Responsible for drug business related license application and renew.

3.Collect and analyze quality information, monitor the implementation of related laws and regulation in concerned departments and positions.

4. Responsible for change control management.

5.Organize the preparation of monthly quality report (Tier 1 report) and quality management review.

6.Organize quality risk management, carry out continual improvement on quality system.

7.Responsible for quality query and the investigation, handling, report of quality complaint.

8. Report counterfeited product.

9.Support DS to conduct safety events of drug reporting and monitoring.

10.Assist to carry out the education and training in quality management field.

11.Act as local leader user of *** system.

12. Supervise the health of personnel directly contacting with drug.

13. Responsible for recall and alert management.

14.Manage CAPA.

15.Coordinate health authority inspection.

16.Coordinate self-inspection and internal audit.

17.Support distributor qualification and audit.

18.Review and approve finished goods license and distributor related license in SAP and GTS.

19.Other duties as assigned by supervisor.

任职要求：

1.Good English skill at reading, writing，listening and specking.

2.Bachelor degree or above in pharmacy，biology，chemistry，medicine or other related area.

3. Licensed Pharmacist (Mandatory）

4.Above 3 years quality experience in GMP or GDP (GSP) area

5.Willing and able to travel at least 30% of the time.