锦鲤求职岗位描述
岗位职责
1. 负责变更、偏差、CAPA的全过程管理。
Responsible for the whole process management of change control, deviation and CAPA.
2. 负责完成变更、偏差、CAPA的定期回顾，并起草回顾报告。
Responsible for the quarterly review of change control\deviation\CAPA and initial quarterly review report.
3. 负责质量管理回顾相关工作，定期组织高级管理层参与的质量管理回顾汇报会议。
Responsible for quality management review related work, regularly organize senior management participation in quality management review reporting meetings.
4. 负责质量风险管理。
Responsible for quality risk management.
5. 负责供应商管理体系相关工作。
Responsible for supplier management system.
6. 负责产品投诉和召回工作的处理。
Responsible for product complaint and recall.
7. 负责客户审计和官方审计。
Responsible for the customer audit and regulatory audit.
8. 负责年度内审的计划，安排和实施。
Responsible for the planning, arrangement and implementation of annual internal audit.
9. 负责公司GMP文件及空白记录表格的生成，审核，发放， 回收等工作。
Responsible for the generation, review, release, and recovery of GMP documents and blank record forms.
10. 负责GMP档案室的管理，负责GMP档案的接收、借阅、检查、保存与转移过程，并监督各部门GMP文件的归档。
Responsible for the management of GMP archive room; Responsible for receiving, borrowing, checking, retention and transferring of GMP archives, and supervise the archiving of GMP documents in all departments;
11. 负责培训管理，组织员工培训档案建立和维护，年度 GMP培训计划起草，监督年度GMP培训计划的执行。
Responsible for training management. Organizing staff training files establish and maintain, drafting annual GMP training plan, and supervising the implementation of annual GMP training plan;
12. 遵守公司的规章制度，遵守保密制度，坚持保密原则。
Obey the regulations of company, obey the confidential regulation and insist the confidential principle.
13. 完成上级交办的其他工作。
Finish the other jobs assigned by the supervisor.
教育程度/经验：
Education/Experiences
1. 本科及以上学历，生物制药相关专业；
Bachelor degree above, biopharmaceutical major;
2. 5年以上药品或生物制药QA的工作经验；
At least 5 years of pharmaceutical QA working experience.
技能要求：
Skills
1. 良好的英语读写能力。
Well verse in reading and written English.
2. 熟练的使用计算机办公软件。
Skillful in using computer software.
3. 有良好的沟通技巧，工作认真、细致，具有良好的团队合作精神。
Good communication skill, attentive, careful and meticulous, with strong team-work ability.
4. 熟悉欧盟、中国和美国GMP法规相关要求。
Familiar with GMP regulations and requirements of EU, CFDA, and FDA.