1. Manage monthly trending metrics an d presentation of the following QMS:管理月度趋势指标和以下质量管理体系报告：- Failure Investigation system （NOE, NCRs, CAPA, Laboratory Investigation, Vendor Corrective Action Report , Customer Complaint）失效调查系统（事件通知，不符合项报告，纠正措施及预防措施，实验室调查，供应商纠正措施报告，×××投诉）- Water Test Monitoring （Potable, Purified Water, WFI）水试验监测（饮用水，纯化水，注射用水）- Pure steam纯蒸汽2. Change Control metrics for the current month in comparison with previous month.对比上月和本月变更控制指标3. Manage semi-annual Quality trending metrics an d presentation in accordance to A-G-SOP-21004根据A-G-SOP-21004管理半年度质量趋势标准和报告。4. Manage, coordinate, an d present Annual Product Reviews preparation an d presentation.管理、协调和展示《年度产品审核》，制定和提交。5. Devises sampling procedures an d designs an d develops forms an d instructions for recording, evaluating, an d reporting quality an d reliability data.制定取样规程，设计和制定记录、评估和报告质量和可靠性数据的表格和说明。6. Provides support to QA incoming engaged in measuring an d tabulating data concerning materials reliability.协助QA来料对涉及物料可靠性的数据进行测量并制表。7. Provides support to QA in process engaged in measuring an d tabulating data concerning in process quality an d finished product reliability.协助QA来料对有关中间过程质量和成品可靠性的数据进行测量并制表。8. Provides support to QC engaged in data measuring an d tabulating data concerning materials, process quality an d reliability.协助QC对涉及物料、工艺质量和可靠性的数据进行测量并制表。9. Maintain the site on-going Reduced Testing Program for API, excipients, packaging materials an d other materials if applicable.如适用，维护现场正在进行的原料药、辅料、包装物料和其它物料的缩减测试程序。10. Product Yield an d rejections evaluation for establishing rejection rates. Trending an d evaluation for reconciliation of materials.产品收率和不合格率评估建立不合格品率。物料平衡率趋势和评估。 11. Leads the overall activities related to the site quality continue improvement program.领导与现场质量持续改进程序有关的全部活动。12. Performed any other task assigned by the direct supervisor.执行直接主管分配的其它任务。24