1. Monitor and assure compliance (with domestic and international GMPs) of the production system (drug substance and drug product), labeling and packaging system, and material system with domestic and international GMP requirements
监督并确保生产系统(原液和制剂)，标签和包装系统，物料仓库系统的合规符合性（符合国内和国际GMP要求）；
2. Review documents of production system, labeling and packaging system and material system according to established procedure.
根据建立的程序执行生产系统，包装与标签系统和物料系统的文件审核；
3. Review quality events，such as surveys from deviation, OOS, complaint, return and recall, as well as corresponding CAPA activities according to established procedure..
根据建立的程序审核质量活动，如偏差、OOS、投诉、退货、召回的调查，以及相应的CAPA活动；
4. Review change control, qualification and validation activities according to established procedure.
根据建立的程序审核变更、确认和验证活动；
5. Audit quality management documentation covering the validation lifecycle of CBL facilities, utilities, equipment, and processes (i.e. VMP, VP, URS, FS, OS, Protocols, Reports) according to established procedure.
根据建立的程序审核质量管理文件，包括 CBL 设施、公用设施、设备和过程的验证生命周期（即VMP、VP、URS、FS、OS、协议、报告）
6. Continuously improving the Company QMS.
持续改进公司质量管理体系；
7. Support the internal, regulatory, client and third party audits.
支持内部审计、监管机构检查、客户审计和第三方审计
8. Support the other activities related to the PAI Readiness program.
支持其他与PAI准备计划相关的活动;
9. Compliance with corporate and site safety procedures. Zero lost time injuries for staff.
遵守公司和现场的安全程序、员工零工伤；
10. Comply with the company's information security management related system and requirements
遵守公司关于信息安全管理的相关制度和要求;