工作职责：
Working Responsibility:

1. 负责检验记录、生产记录和其他相关记录的审核。
Responsible for review of testing record, production record and other related record.
2. 负责中间产品，最终产品的放行审核。
Responsible for review of release of inter-production and final product.
3. 验证方案、报告的审核。
Responsible for review of validation protocol and report.
4. 负责生产、分析现场日常检查。
Responsible for working area check of analytical lab and workshop.
5. 参与内部审计和外部审计。
Participating in internal audit and external audit.
6. 负责年度回顾、调查、变更、偏差、风险评估、纠正预防措施和投诉等审核。
Responsible for review of annual product review, investigation, Change Control, Deviation, risk assessment, CAPA, Complaint and so on.
7. 负责与CMO沟通和持续的质量监管，确保委外项目符合目标市场法规指南和公司质量体系要求
Responsible for communicating with CMO and continued quality oversight to ensure that outsourced projects meet the requirements of target market regulations and our company quality system。
8. 负责向上级汇报发现的问题。
Responsible for report problem to line manager.
9. 负责上级领导分配的其他任务。
Responsible for working task designed by leader.