Associate-QA Compliance

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岗位描述 Position Description:

该岗位为工厂合规QA，负责通过构建、完善、执行和监督质量流程来保障工厂质量体系的全面合规性。持续监督本地法规、药品生产质量管理规范以及礼来公司全球质量准则要求的实施，并按适当的管控措施及时上报潜在合规性风险。

This role serves as site Compliance QA, is responsible to ensure the overall compliance of the site quality systems by building, improving, executing and monitoring strong quality process. To monitor for compliance with local regulations, the requirements of GMPs and Lilly Global Quality Standard, and report potential compliance risk in a timely manner through appropriate governance.

主要职能 Key Objectives/Deliverables:

作为偏差管理系统负责人

As Deviation Management System owner role

• 负责工厂偏差管理规程的维护，确保符合礼来质量准则和目标市场的法规要求。Maintain the site procedure for Deviation Management, to ensure compliance with the requirements from Lilly Quality Standards and Intended markets regulations.
• 负责偏差审核会议，并定期对偏差进行趋势分析。Facilitate Review Board, and conduct deviation trend analysis periodically.
• 作为偏差管理系统的讲师，对工厂员工进行因果关系图、偏差书写技巧等培训。As trainer for deviation management system, provide training of Causal Factor Chart and Deviation Technical Writing, etc for site users.
• 参加总部会议、与总部业务专家持续沟通及与其他工厂交流最佳实践，以支持工厂偏差管理系统的持续改进。Participate in global team conference, continuously improve the deviation management system.

负责维护工厂质量合规相关文件，包括质量手册、场地管理文件、质量体系的管理评审等。

Be responsible for maintaining documentations relevant to the quality compliance, including Site Quality Manual, Site Master File, Management Review of Quality System, etc.

其他与质量相关的事项，如：

To assume other tasks related to QA, such as:

• 参与偏差调查、变更执行等活动 To take part in deviation investigation, change execution etc.
• 对其他部门提供改进建议和服务To provide good services and recommendations to other departments for improvement
• 完成主管安排的其他任务
  Other jobs assigned by supervisor

遵守HSE各项管理流程，履行安全生产职责要求

Follow various HSE management procedures and fulfil the work safety responsibilities.

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