南湖人才网_南湖招聘网_求职找工作平台

Contractor，有機會轉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
審閱涉及中控和成品的日常生產、環境監測和質量控制數據；及時檢查并記錄所有與批次相關的文件，協助完成產品的放行并確保滿足以下要求：
a) All the necessary checks and tests have been performed 完成所有必要的檢查和測試
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
所有必要的生產文件均由合格且認可人員完成，符合賽諾菲質量政策，當地法規和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
在任何產品放行前，已根據明確定義的系統通知和評估生產或質量控制方面的任何變更或偏差
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
參與偏差調查和變更，在及時識別、調查和解決可能影響產品和過程質量的偏差方面，表現出較高的獨立判斷力；在跨職能調查期間以及在需要時提供支持和建議；參與制定取樣計劃和方法以記錄和報告質量數據；參與發起糾正和預防措施，支持CAPA的實施并檢查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.
協助完成產品質量回顧，確保PQR 按照相應的程序和GMP 要求及時完成。
4. As a member of COP PQR, assist in completing the GenAIR project for PQR.作為PQR Cop的一員，協助完成PQR 的GenAIR項目。
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
根據個人年度培訓計劃和其他培訓完成個人培訓。進行有關藥品生產，質量管理體系和GMP方面的培訓
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、審閱和修訂SOP和任何其它與工廠/產品有關的文件，以確保文件水平足夠并符合現有流程
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
參與工廠的定期質量審計；支持外部現場審計；評估審核結果并參與執行適當的糾正措施
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
參與確認和驗證管理活動，包括涉及設備、工藝、方法和API /輔料/內包材/關鍵物料規格等的活動；審查生產相關文件.支持變更控制的審閱與實施
9. Complete other duties as designated by the superior
完成上級指派的其它工作
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