QA Specialist/Senior QA Specialist

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Responsibilities:
1. On behalf of Company QA, ensure cGMP compliance in CMO companies in daily production operations, especially during the time manufacturing APIs and IMPs;
2. Eliminate or at least reduce the deviations, involved in the investigation for OOS and deviations occurred in products; CAPA implementation following up after auditing reports;
3. Familiar with the regulations and GMP requirements in manufacturing process for API synthesis and oral solid dose production;
4. Review and finalize the quality specifications for each API and finished product, eliminating the risk of missing any required testing in quality controls;
5. besides GMP and GLP knowledge, also understand the principle of good scientific practice (GSP) for data authenticity, data accuracy and data safety;
6. Involved in SOP review in non-CMC departments;
7. Good interpersonal and coordination skills;
8. Able to travel for business trip;

Qualification:
1. BS or above in Chemistry, Biochemistry and Pharmaceutical Science
2. 2 years QA experience in international pharmaceutical company
3. CET-6 or above