QA专员（原液生产现场）

1. Participate in the compliance review of Production Department (DS)
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(原液)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；
2. Oversee GMP compliance of the operation and on-site management of Production department (DS).
监督生产（原液）部门的操作和现场管理的GMP合规性；
3. Participate in the handling of Production department (DS) related quality events, including deviation, change control, CAPA, etc.
参与生产部门(原液)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 cell bank and product (DS) release activity，including information tracking, document sorting and review. Ensure the product release is completed within the specified timeline.
参与细胞库和产品(原液)放行工作，包括信息追踪，文件整理和审核。确保按照管理流程要求并在规定时限内完成细胞库和产品放行。
5. Oversee the data integrity compliance of related area.
监督相关区域数据完整性的合规性。
6. Participate in the internal audit (self-inspection), and external audit.
参与内审（自检）和外审。
7. Complete the other tasks as assigned.
完成分配的其他工作。