岗位职责： 1.领导偏差调查工作、变更实行、纠正和预防措施的执行。 Lead deviation investigation, change control and CAPAs execution. 2.负责商业化微生物GMP生产部门外部客户和**GMP审计和公司内部质量保证部门的内审。 Responsible for external ****** audits and official GMP inspection, internal QA audit in the microbiology commercial GMP manufacturing department. 3.组织生产系统质量管理的有效实施、监管和维护，基于风险管理方法保证符合所有国内和国际相关法规的要求。 Organize the effective implementation, supervision and maintenance of quality management of production systems, based on a risk management approach to guarantee compliance with all relevant national and international regulations. 4. 协助部门内各团队GMP符合性的管理。 Assist each team in management of GMP compliance within the department. 5.及时向领导反馈工艺、人员、安全、生产环境、维护及其他问题。 Communicate status of process，personnel，safety，environment，maintenance and other issues in a timely manner to his/her director. 6. 负责管理回顾活动、培训策略、审计、设备管理、物料管理及其他与工艺及系统相关的文件。 Responsible for managing retrospective activities, training approach, audits, equipment management, materials management and other documents related to processes and systems. 7. 负责起草和审核GMP相关文件，包括但不限于SOP/URS/FAT/SAT。 Responsible for drafting/reviewing SOP/URS/FAT/SAT or other GMP related documents. Qualification: 1.微生物学，生命科学, 制药，生物工程或相关专业本科或以上学历； Have bachelor’s degree or above in microbiology, biology, Pharmacy, Biotechnology or other life science subjects with 4 years above industry experience. 2.具有4年以上微生物商业化生产质量管理经验。 4 years and above quality related experience in commercial manufacturing of microbiology is required 3.熟悉微生物制品相关法规，和GMP体系，善于沟通和合作，逻辑思维能力强 Familiar with related microbiological regulation and cGMP knowledge; Have good communication, cooperation and logical skills 4.熟练的英语听说读写能力； Proficient communication skills in written, oral English is requi*******************