上海市 | 1人
• 工作职责：
1. Conduct work described in the related SOPs and according to OECD, US FDA and NMPA, etc., GLP guidelines as well as other applicable regulations.
2. Conduct facility inspection, special inspection, computerized system audit, vendor/contractor audit, etc., and review SOP when necessary.
3. Conduct study-based audit; including plan/protocol review, experimental phase inspection, data audit, report audit and report verification etc.
4. Promptly report any inspection results in writing to management and to the Study Director, or to the Principal Investigator(s) and the respective management, when applicable; Follow up implementation of CAPA, when applicable.
5. Maintain QA files.
6. Assist inspections by client or regulatory agency when necessary.
7. Assist and advise QA management on quality system improvement.
8. Conduct the work delegated by QA management.
任职资格：1.BS or MS degree in a science discipline with experience or training in biochemistry, biotechnology, analytical chemistry, chemistry, pharmacy or related disciplines.
2. Be skillful at reading, understanding and writing English documentation.
3. Have good communication skills, both written and verbal, and work in a team-oriented manner.