工作职责：
负责生产、设备设施、计量等现场监控; Responsible for production, equipment and facilities, metering and other on-site monitoring
参与生产过程产生的相关偏差调查; Responsible for participating in the production process of the relevant deviation investigation;
参与生产、设备设施相关变更工作；Responsible for participating in production, equipment and facilities related changes;
负责公司产品年度质量回顾报告的起草; Responsible for the drafting of the annual product quality review report;
参与公司年度自检生产部门的自检工作；Responsible for participating in the annual self-inspection of the company's production department;
负责工艺规程、岗位操作法、质量标准、工艺验证、清洁验证、设备验证等审核; Responsible for process procedures, post operation methods, quality standards, process verification, cleaning verification, equipment verification and other audits;
负责原料、中控、中间体检验原始记录、批生产记录审核；·Responsible for raw materials, intermediate control, intermediate inspection of original records, batch production records review; ,
组织和参与对生产人员的质量培训，包括质量意识、SOP 培训、GMP培训等; Organize and participate in quality training for production personnel, including quality awareness, SOP training, GMP training, etc.
任职要求：
1.本科及以上学历，药学、制药工程相关专业；
2.至少2年药品生产质量管理经验；
3.CET-4.