Field QA team leader Work location Room A708, Building 1, No.600 Huaxi Road, Minhang District, Shanghai Job type Management position Job responsibilities 1, according to the production plan, coordinate personnel to complete the environmental monitoring, sampling, sampling, inspection and other daily work of the preparation site;2. Participate in the investigation of abnormal conditions in preparation production and engineering and give preliminary investigation conclusions. Including ensuring that changes, deviations, CAPA, OOS, OOT related to preparation production and engineering are investigated and give preliminary review opinions, participating in the investigation of complaints and returns related to product quality, and giving preliminary investigation conclusions and improvement directions;3. Ensure that the batch production records and batch packaging are reviewed before product release;4. Ensure that monthly and quarterly environmental monitoring, pure steam sampling, compressed air sampling and other periodic work are reasonably planned and implemented;5. Review documents related to preparation production and engineering departments, including verification plans, verification reports, batch production records, batch packaging records, relevant operating procedures and equipment maintenance procedures, and give preliminary review opinions;6. Coordinate the drafting, revision and preliminary review of documents related to on-site QA of preparations;7. Organize and draft the annual quality review analysis report of products, environment and common media and conduct preliminary review.8, responsible for on-site supervision of the on-site production of commissioned products (MAH resident QA) Qualification 1, college degree or above, pharmacy related major;2,3 years working experience in aseptic preparation pharmaceutical company;3. Have excellent ability to promote execution, improve daily work and improve production efficiency;4, familiar with regulations, including but not limited to Chinese pharmacopoeia, GMP regulations, understanding of foreign regulations is preferred.