1. Manage monthly trending metrics and 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，客户投诉）

- 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 and 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, and present Annual Product Reviews preparation and presentation.

管理、协调和展示《年度产品审核》，制定和提交。

5. Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and 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 and 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 and tabulating data concerning in process quality and 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 and tabulating data concerning materials, process quality and 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 and 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 and rejections evaluation for establishing rejection rates. Trending and 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.