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Contractor，有機(jī)會轉(zhuǎn)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(chǎn)、環(huán)境監(jiān)測和質(zhì)量控制數(shù)據(jù)；及時檢查并記錄所有與批次相關(guān)的文件，協(xié)助完成產(chǎn)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(chǎn)文件均由合格且認(rèn)可人員完成，符合賽諾菲質(zhì)量政策，當(dāng)?shù)胤ㄒ?guī)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(chǎn)品放行前，已根據(jù)明確定義的系統(tǒng)通知和評估生產(chǎn)或質(zhì)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(diào)查和變更，在及時識別、調(diào)查和解決可能影響產(chǎn)品和過程質(zhì)量的偏差方面，表現(xiàn)出較高的獨(dú)立判斷力；在跨職能調(diào)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(zhì)量數(shù)據(jù)；參與發(fā)起糾正和預(yù)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(xié)助完成產(chǎn)品質(zhì)量回顧，確保PQR 按照相應(yīng)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(xié)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(jù)個人年度培訓(xùn)計劃和其他培訓(xùn)完成個人培訓(xùn)。進(jìn)行有關(guān)藥品生產(chǎn)，質(zhì)量管理體系和GMP方面的培訓(xùn)
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(chǎn)品有關(guān)的文件，以確保文件水平足夠并符合現(xiàn)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(zhì)量審計；支持外部現(xiàn)場審計；評估審核結(jié)果并參與執(zhí)行適當(dāng)?shù)募m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(rèn)和驗證管理活動，包括涉及設(shè)備、工藝、方法和API /輔料/內(nèi)包材/關(guān)鍵物料規(guī)格等的活動；審查生產(chǎn)相關(guān)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