Main Responsibilities 主要职能：
1. Perform GMP compliance supervision and inspection of production site, laboratory, validation, warehouse and utility system operation.
执行生产现场、实验室、验证、仓库及公用系统运行的GMP符合性监督检查；
2. Responsible for the review and evaluation of all batch production and inspection records to ensure that materials and products are released in compliance.
负责所有批生产记录、批检验记录的审核、评估，确保物料及产品合规放行；
3. Responsible for the management of abnormal issue, deviation, change control, complaints, etc., to find the root cause and develop effective preventive and corrective measures, and track the effectiveness of CAPA.
负责异常、偏差、变更、投诉等的管理，寻找根本原因并制定有效预防纠正措施，并跟踪CAPA有效性；
4. Support quality management review, regularly review key indicators such as quality system, deviation, change control, CAPA, OOS and material supply issue, and prepare monthly, quarterly and annual reports to ensure continuous improvement of quality system
支持质量管理评审，对质量体系、偏差、变更、CAPA、OOS、物料供应等关键指标进行定期回顾，确保质量体系持续改善；
5. Responsible for product annual review report, finish timely.
负责产品质量年度回顾报告，按时完成。
6. Organized quality compliance training as the enterprise trainer to improve company GMP quality awareness;
作为培训师在公司内部组织质量合规培训，提高人员GMP质量意识；
7. Organize the implementation of quality risk management, effectively improve the level of GMP compliance on site.
参与质量风险管理工作的开展，有效提升现场GMP符合性水平；
8. Paticipient in internal audit, supplier audit and support annual performance evaluation of suppliers;
参与内审、供应商审计，支持物料供应商年度绩效评估；
9. Suppport quality system QA relevant work, such as material，consumbales assessment and approval.
支持体系QA相关工作，如物料/耗材评估、批准等
10. Follow the EHS requirement and ensure daily 5s management.
遵守公司EHS 要求，确保良好的日常5S管理；
11. Responsible for team daily work arrangement, work feedback, formulate development plan and supervise the effective implementation; Perform annual performance evaluation.
负责团队日常工作安排，人员工作反馈，制定员工发展计划并监督有效执行；执行年度绩效评估；
12. Complete other tasks assigned by the line manager: internal technology sharing, teaching new staff training, etc.
完成主管分配的其它任务：团队内部技术分享、带教新员工培训等。
Qualification and Specification 任职资格：
1. Bachelor or above Degree
本科及以上学历；
2. Pharmacy, microbiology, biology and other medical related majors;
药学、微生物学、生物学等医药相关专业；
3. At least 3 years experience in pharmaceutical quality management;
3年以上药品质量管理经验；
4. Experience in manufacturing site of Sterile preparation enterprise is preferred
有无菌制剂企业生产现场的管理经验优先；
5. Experience in biological pharmaceutical QA or QC inspection is preferred
有生物药QA经验或QC检验经验者优先；