体系QA

1. 作为CCRB负责对变更进行审核及判级，如需要约会讨论。

Responsible for reviewing and classifying change control (act as CCRB), to have meeting for discussion when needed.

2. 负责对变更、偏差、CAPA的趋势分析，及时发现不良趋势并上报；

Responsible for the trend analysis of changes, deviations and CAPA, reporting non-conformity trend in time.

3. 产品投诉/产品召回

Product Complaint/Product Recall

4. 负责起草、修订、审核投诉、召回等相关文件及记录.

Responsible for drafting, revising, reviewing of product complaint, recall, etc.

5. 负责质量协议中质量体系相关内容的审核

Responsible for reviewing the quality system related contents in the QAA.

6. 负责过程控制管理、污染控制策略，风险评估活动.

Responsible for process control，CCS and risk assessment, etc.

7. 负责组织法规差距分析及行动跟踪

Responsible for organizing gap analysis and tracking relevant action

8. 参与公司内外部审计，回复客户和官方审计，并追踪改正措施的执行情况；

Participate in internal and external audit and respond to client and/or official audit. Follow up corrective action implementation;

9. 负责维护工厂主文件，根据厂区运行情况，升版相关文件，确保符合法规需要。

Responsible for maintaining and updating site master file based on the operation to meet the regulation requirements.

10. 负责维护和优化偏差处理程序，纠正和预防措施程序，变更控制程序，质量风险管理程序。

Responsible for maintaining and optimizing handling of deviations procedure, corrective action and preventive action procedure, change control procedure, quality risk management procedure.

11. 负责质量回顾数据审核，组织开展质量回顾会议

Responsible for quality review data collection, organizing quality review meetings.

12. 负责质量管理评审会议的组织、汇报和整改项跟进，负责上报管理

Responsible for organizing and presenting in the quality management review meeting, following up the actions and escalation management.