1. Responsible for the management of copying, issuing, recalling, archiving ，retention，obsoleting of all GMP related documents an d records.负责管理所有与GMP相关的文件和记录的复印、发布、召回、存档、保存及作废。2.Responsible for coordinating training with the marketing group for managing complaints, field alerts, an d recalls.负责与市场营销小组协调培训，共同管理投诉、现场警告和召回。3.Manage an d review 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）.及时管理并审核所有的失效调查，维护失效调查文件和记录（例如：事件通知、不符合性报告、超标、纠正预防措施、计划性偏差、供应商纠正措施。）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相关事件的升级，以确保及时采取适当的措施。5. Review an d approve all changes related to quality GMP activities.审核和批准所有与GMP活动相关的变更。6.Review an d approve all qualification summary reports （QSRs）.审核和批准所有的确认总结报告。7.Monitor the debarment list an d Adverse Event Reporting’s.跟踪禁令列表/黑名单和不良事件报告。8.Prepare, review, implement an d maintain Documentation / Archive SOPs.起草、审核、实施和维护文件/SOP的存档。9.Prepare, review, implement an d maintain numbering systems for all document.起草、审核、实施和维护所有文件的编号系统。10.Prepare, review, implement an d maintain standard formats for all documents. 起草、审核、实施和维护所有文件的标准格式。11.Prepare, review, implement an d maintain logs for all GMP documents. 起草、审核、实施和维护所有GMP文件的日志。12.Maintain all forms for GMP activities.维护所有GMP活动的表格。32