工作职责： Ensure all engaged operation activities conform to Laws and Regulations related to Drug and GMP, Guideline from Global Quality and so on. 确保所有负责的运作符合药品及GMP相关的法规要求、总部指导方针等。 Coordinate the deviation and CAPA management; make sure that fully investigation and corrective measures must be taken. Coordinate related departments to fully investigate any deviations that is not conform to GMP and SOP requirements during production process. 协调偏差和CAPA管理，以确保调查及相应的纠偏措施已执行。协调相关部门处理生产过程中不符合GMP及SOP规定的偏差事件进行调查。 Handle the customer complaints and support related investigation about ADR case. With regard to defects which are found, CAPA should be taken and the validity of them should be evaluated. 管理客户投诉和支持ADR事件的相关调查，确保过程中发现的缺陷项目有相应的纠偏措施文件，并检查其有效性。 Be responsible for quality evaluation of returned /rework /reprocess products and abnormal materials found during production. 负责给出退回、返工产品和生产过程中异常物料的质量评估。 Participate in site self- inspection. 参与工厂GMP自检。 Revise the relevant SOPs to ensure operations conform to SOPs. 根据GMP要求和实际日常工作情况及时更新相关sop，确保操作与sop一致。 Participate in completing job related APR, monthly /QMR/Dashboard report. 参与完成工作相关的年度质量回顾报告、各种相关月报。 Revise the relevant SOPs to ensure operations conform to SOPs. 根据GMP要求和实际日常工作情况及时更新相关sop，确保操作与sop一致。 Be responsible for reviewing the batch record of products as back up. 负责产品的批记录审核的备员。 If necessary should undertake other work of QA team. 必要时，应承担QA团队其他工作。 任职要求 Main INTERFACES: PD生产部、FE设备部、SC物流部、QC及工厂其他部门 Qualifications (Knowledge, Skills, Competencies & Expectations): 资质要求（知识、技能、能力&期望） Knowledge: 知识 Bachelor degree or above, major in chemistry, pharmaceutical, microbiology related. 大学本科或以上学历，化学、药学或生物相关专业优先。 Over 3 years relevant work experience in pharmaceutical manufacture industry, produce injection experience is a plus. 3年以上医药行业相关工作经验，有注射剂领域的质量经验优先考虑。