Contractor，有机会转FTE
Major Responsibility:
1. Review routine manufacturing, environmental monitoring and quality control data for in-process and finished products; review and record all batch related documentation timely, assist in release of finished product and ensure that following requirements have been met
审阅涉及中控和成品的日常生产、环境监测和质量控制数据；及时检查并记录所有与批次相关的文件，协助完成产品的放行并确保满足以下要求：
a) All the necessary checks and tests have been performed 完成所有必要的检查和测试
b) All necessary production documentation has been completed and endorsed by qualified personnel and is in compliance with Sanofi quality policy, local regulatory and GMP requirements
所有必要的生产文件均由合格且认可人员完成，符合赛诺菲质量政策，当地法规和GMP要求
c) Changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any products is released
在任何产品放行前，已根据明确定义的系统通知和评估生产或质量控制方面的任何变更或偏差
2. Participant in deviation investigations and change controls by demonstrating a high level of independent judgment and discretion in the timely identification, investigation and resolution of deviations potentially impacting the quality of products and processes; provide support and advice during cross functional investigations and when required; participate in devising sampling procedures and directions for recording and reporting quality data;.Participate in the initiation of corrective and preventative actions, support CAPA implementation and review
CAPA effectiveness
参与偏差调查和变更，在及时识别、调查和解决可能影响产品和过程质量的偏差方面，表现出较高的独立判断力；在跨职能调查期间以及在需要时提供支持和建议；参与制定取样计划和方法以记录和报告质量数据；参与发起纠正和预防措施，支持CAPA的实施并检查CAPA的有效性
3. Assist in product quality review and ensure the PQR is completed following relevant procedure and GMP requirements in timely manner.
协助完成产品质量回顾，确保PQR 按照相应的程序和GMP 要求及时完成。
4. As a member of COP PQR, assist in completing the GenAIR project for PQR.作为PQR Cop的一员，协助完成PQR 的GenAIR项目。
5. Complete personal trainings according to individual annual training plan and other training requirements. Conduct training in aspects related to pharmaceutical product manufacturing, Quality Management Systems and GMP
根据个人年度培训计划和其他培训完成个人培训。进行有关药品生产，质量管理体系和GMP方面的培训
6. Draft, review and revise SOPs and any other site/product related documents ensuring adequate levels of documentation and compliant to existing procedures
起草、审阅和修订SOP和任何其它与工厂/产品有关的文件，以确保文件水平足够并符合现有流程
7. Participate in regular quality audits of the site; support on-site audits conducted by external providers; evaluate audit findings and participate in the implementation of appropriate corrective actions
参与工厂的定期质量审计；支持外部现场审计；评估审核结果并参与执行适当的纠正措施
8. Participate in qualification and validation management activities, including those covering equipment, processes, methods, and API/excipients/primary packaging materials/critical supplies specifications etc.; review production-related documents. Support the review and implementation of Change Controls
参与确认和验证管理活动，包括涉及设备、工艺、方法和API /辅料/内包材/关键物料规格等的活动；审查生产相关文件.支持变更控制的审阅与实施
9. Complete other duties as designated by the superior
完成上级指派的其它工作
Requirements:
1. English can be working language especially verbal
2. At least 5 years' QA experiences in pharmaceutical product manufacturing, Quality Management Systems and GMP