南京招聘

职位描述：
Key accountabilities:

1. Reviewing test protocol, records and reports and issue CoA for project and product. Ensuring Specifications, sampling instructions, test methods and other procedures related with GMP operation are effective before using.
2. Coordinating OOS/OOT/OOA, 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.
3. Coordinating change control, making sure any change are documented according to defined procedure and all impacted items are investigated.
4. QA related SOPs writing, revision and reviewing.
5. Periodical quality evaluation with ASU.
6. Taking part in internal audit and routine inspection.
7. Any job and responsibilities assigned by direct supervisor.
工作范围：
Scope of the job:

1. Report to QA leader.
2. Direct report to this position.
3. 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. Must have experience in GMP.
2. Must be trained in or have experience with the requirement of SFDA, FDA, EMEA GMP regulation.
3. BS, MS degree in a science discipline with experience or training in Chemistry, Pharmaceutical, or equivalent experience.
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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