1. Participate in the compliance review of Production Department (DP) related GMP documents and records, including Master Production Instruction, Batch Record as well as related management and operation SOPs, etc.
参与生产部门(制剂)相关GMP文件和记录的合规性审核，包括工艺规程、批记录、和相关管理及操作类SOP等；
3. Participate in the handling of Production department (DP) related quality events, including deviation, change control, CAPA, etc.
参与生产部门(制剂)相关质量事件的处理，包括偏差、变更、纠正与预防措施等；
4. Participate in the review of validation (or qualification) and re-validation (or re-qualification) plans and reports for equipment related to the production department (DP).
参与生产部门（制剂）相关设备验证（或确认）和再验证（或确认）方案和报告的QA审核；
5. Oversee GMP compliance of the operation and site management of Production department (DP).
监督生产（制剂）部门的操作和现场管理的GMP合规性；
6. Oversee the data integrity compliance of related area.
监督相关区域数据完整性的合规性；
7. Participate in AQL as required.
根据内部工作分工需要参与AQL。