1. Responsible for the management of copying, issuing, recalling, archiving ，retention，obsoleting、 of all GMP related documents an d records.负责所有GMP相关的文件及记录的复印、发放、收回、归档、保管、废止等管理工作。2.Responsible for coordinating training with the marketing group for managing complaints, field alerts, an d recalls. 负责与营销部协调管理投诉、现场预警及产品召回的记录管理等。3.Manage in a timely manner all failure investigations an d maintain failure investigation documentation an d logs （e.g., NOE, Non Conformance, OOS, CAPA, Planned Deviations, Vendor Corrective actions）.及时管理所有失效调查并维护失效调查文件和台账记录（例如：NOE、不符合报告、OOS、CAPA、计划偏差、供应商纠正措施等）。4.Responsible for escalation of product quality an d GMP related incidents to ensure that prompt an d appropriate action is taken. 负责产品质量和GMP相关事件的上报记录的管理工作，确保采取及时、有效地的措施。5.Review an d approve all changes related to quality GMP activities.审核、批准与GMP质量活动有关的所有变更。6.Review an d approve all qualification summary reports （QSRs）.审核、批准所有确认总结报告（QSRs）。7.Monitor the debarment list an d Adverse Event Reporting’s.监督排除清单和药品不良反应报告。8.Prepare, review, implement an d maintain Documentation / Archive SOPs.制定、审核、实施并维护文件记录/归档SOP。9.Prepare, review, implement an d maintain numbering systems for all document制定、审核、实施并维护所有文件的编号系统。10.Prepare, review, implement an d maintain standard formats for all documents. 制定、审核、实施并维护所有文件的标准格式。11.Prepare, review, implement an d maintain logs for all GMP documents. 制定、审核、实施并维护所有GMP文件的台账。12.Maintain all forms for GMP activities.维护所有GMP活动的表格。32