上海招聘

职位描述：
关键职责：
Key accountabilities:

1. Reviewing and approving the analytical records according to defined procedure or specification, to ensure accuracy and reliability of testing figures.
2. Reviewing method validation/transfer/verification, Stability sample testing, client sample testing, etc.
3. Reviewing and issue CoA for project and product.
4. Supporting the validation activities and ensuring that the appropriate validations are done according to VMP and defined procedures. Reviewing validation protocol and report.
5. Coordinating OOS/OOT/OOA/ATY, deviations, CAPA, making sure the corrective or preventative actions are carried out and documented and maintaining the trace system to prevent deviations from re-occurring.
6. Coordinating change control, making sure any change are documented according to defined procedure and all impacted items are investigated and evaluated, making sure the proposal changed implement as the requirements of pre-defined protocol.
7. Taking part in related internal audit; conducting routine inspection for laboratory and ensuring the lab compliance. Review logbook.
8. Taking part in client audit.
9. Communicate with clients. Send deviation /Change control or other documents to client.
10. Taking part in QA analytical related SOP’s writing, revision and reviewing.
11. Be responsible for training new staff.
12. Be responsible for providing GMP/quality assurance related training (GDP,DEV).
13. Any jobs and responsibilities assigned by supervisor.

工作范围：
Scope of the job:

1. Report to QA head.
2. Work with PDS, ASU and Engineering department to ensure that requirement of CGMP and customer are met.


核心工作/职业技能和教育背景：
Core business/Functional skills and education:

1.Overseas study for MS or PhD in pharmaceutical or related science field, good communication skills in both English and Chinese
2.Experience in QC lab to support drug substance or drug product testing and releasing as well as stability studies
3.Experience in hosting customer audits or health authority inspections
4.Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
5.Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives. 举报 分享

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