Responsibilities: 工作职责 Be responsible for electronic document system management (make effective, distribution, recovery, filing, document transfer, master list maintenance, document periodic review), artworks management of secondary Packaging Material (label, leaflet, single box, carton). 负责电子文件体系的管理包含文件生效，分发，回收，归档，文件转移，主清单维护，文件复查和外包装材料（标签、说明书、单盒、大箱）文稿的管理。 Be responsible for related GMP training, including annual training plan, quarterly training summary, training record registration, online learning marking in learning management system,, new employee qualification confirmation, training record review and filing, training effect evaluation, physical examination review 负责GMP相关培训包括年度培训计划，季度培训汇总，培训记录登记，网上学习阅卷，新员工上岗资质确认，工厂培训记录审核及归档，培训效果评估，体检复核。 Coordinate related department to fully investigate any deviations that is not conform to GMP and SOP requirements in warehouse area , make sure corrective measures to be taken. 协调相关部门对仓储过程中不符合GMP及SOP规定的偏差事件进行调查，确保相应的纠偏措施被执行。 Participate in supplier audit. 参与供应商审计工作。 Participate in job related APR. 参与完成工作相关的年度质量回顾。 Participate in self- inspection. 参与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。 根据需要，承担部分现场查证工作。 If necessary should undertake other work of QA team. 必要时，应承担QA团队其他工作。 Knowledge: 知识 Soft Skills/Competencies: 技能/能力 College degree or above, major in chemistry, pharmaceutical, microbiology related. 大学专科或以上学历，化学、药学或生物相关专业优先。 Sense of responsibility, diligent and with high integrity, Team-work approach. 有责任心、勤奋、正直、诚信，具有团队合作精神； Hard Skills: 硬性技能 Good English skills (especially reading and writing). 良好的英语读写能力。 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。