QA文件主管

岗位职责：
1.Responsible for the management of copying, issuing, recalling, archiving and disposing of all GMP related documents and records.

负责所有GMP相关的文件及记录的复印、发放、收回、归档、销毁等管理工作。

2.Responsible for coordinating training with the marketing group for managing complaints, field alerts, and recalls.

负责与营销部协调管理投诉、现场预警及产品召回等。

3.Manage, review and approve in a timely manner all failure investigations and maintain failure investigation documentation and logs (e.g., NOE, Non Conformance, OOS, CAPA, Planned Deviations).

及时管理、审核和批准所有的失效调查并维护失效调查文件和台账（例如：NOE、不符合报告、OOS、CAPA、计划偏差）。

4.Ensuring that all deviations and OOS have been fully investigated and handled timely.

确保所有偏差和检验结果超标已经过调查并得到及时处理。

5.Responsible for escalation of product quality and GMP related incidents to ensure that prompt and appropriate action is taken.

负责产品质量和GMP相关事件的上报，确保采取及时、有效地的措施。

6.Review batch record completeness prior release.

确保在产品放行前完成对批记录的审核。

7.Approve quality standards, sampling methods, testing methods and other operation procedures of the quality management.

批准质量标准、取样方法、检验方法和其他质量管理的操作规程。

8.Review and approve all changes related to quality GMP activities.

审核和批准所有与 GMP质量活动有关的变更。

9.Review and approve all qualification summary reports (QSRs).

审核和批准所有的确认总结报告（QSRs）。

10.Work closely with the QA Manager to ensure that all elements of the Quality Management System such as: training, SOPs, protocols, validation, qualification, materials specifications, Quality Agreements, are current, fully implemented and in compliance.和QA经理紧密的配合以确保所有的质量管理体系的要素如：培训、SOP、方案、验证、确认、物料质量标准、质量协议，是现行的、已充分实施且符合法规。

11.Release equipment / systems for manufacture / quality control based on QSRs.基于质量总结报告（QSRs）为生产/质量控制放行仪器/系统。

12.Monitor the debarment list and Adverse Event Reporting’s.

排除清单和药品不良反应报告的监控。

13.Prepare, review, implement and maintain Documentation / Archive SOPs.

起草、审核、实施和维护文件/归档的SOP。

14.Prepare, review, implement and maintain numbering systems for all GMP documents.

制定、审核、实施和维护所有GMP文件的编号系统。

15.Prepare, review, implement and maintain standard formats for all GMP documents.

制定、审核、实施和维护所有GMP文件的标准格式。

16.Prepare, review, implement and maintain logs for all GMP documents.

制定、审核、实施和维护所有GMP文件的台账。

17.Maintain all forms for GMP activities.

维护所有GMP活动的记录。

18.Issue uniquely numbered forms for all GMP activities.

为全部GMP活动发放带有唯一编号的记录。

19.Create authorized copies and uncontrolled copies of all GMP documents.

建立所有GMP文件的授权复印件和非控制复印件。

20.Manage GMP document retention and storage.

管理GMP文件的保管和储存。

21.Manage obsoleting of GMP documents.

管理GMP文件的废止。　　

22.The position is designate QP for the release of finished product.

该职位被QP授权产品放行   

23.Complete any other work task assigned by Quality Assurance Manager.