工作职责:

1. Review test protocol, records and reports and issue CoA for project and product. Ensuring Specifications, sampling instructions, test methods and other procedures related with GMP(GMP like) operation are effective before using.

2. Coordinate OOS/OOT/OOA, deviations, CAPA, making sure the corrective or preventative action are carried out and documented , and maintaining the trace system to prevent deviation from re-occurring.

3. Coordinate 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. Taking part in routine inspections, internal audit and external client audit.

任职资格:

1. At least 5 years experience in GMP.

2.Must have experience with requirement of SFDA, FDA,EMEA GMP regulation.

3.BS,MS degree in Chemistry, Pharmaceutical or equivalent experience.

4.Strong communication skills, both written and verbal English are essential requirements.

上班地址：南海路168号