職位描述
職務描述
1. Manage the Physical&Chemical Laboratory ensuring that the equipment is functional (calibrated and well maintained) and suitable for analytical testing. (10%)
管理理化實驗室，確保儀器適合分析測試（得以校正和良好的保養）。
2. Write and maintain documents such as Analytical Methods, Material Specifications, Standard Operating Procedures, etc. (15%)
編寫和保管分析方法、物料質量標準、標準操作規程等文件。
3. Manage workload and resources to ensure timely release of product. Manage the sampling and analysis of raw materials, intermediates, work-in-process, finished products, routine monitoring samples and others. Ensure that testing is carried out in compliance with specifications, Pharmacopeia requirements and the cGMP and analyse the trend of the analytical results. Ensure the OOS investigation is conducted properly. Release the Raw materials, Packaging materials and Semi-product(Imported) according to the test results. （20％）
根據工作量予以合理安排以保證及時放行產品。管理原輔料、中間體、中間制程產品、成品及日常需監控的樣品等的取樣和分析。確保執行的檢測符合質量標準、藥典的要求和GMP的要求，并分析檢驗結果的趨勢。確保正確執行對“超出質量要求的實驗結果”的調查。根據檢驗結果放行原輔料、包裝材料及進口半成品。（20％）
4. Ensure that Reference Standards as well as Standard Solutions are suitable and maintained according to the cGMP. Maintain and control the inventory of chemicals and consumables, including toxic reagents, ensuring that the budget is respected.（10％）
確保標準品和標準試劑適當并按照GMP要求進行保管。保管和控制庫存的化學品和耗材，包括毒品試劑，確保將其控制在預算范圍內。
5. Write the Protocols and perform the Qualification of the laboratory equipment/instruments and the Validation of new Analytical Methods. （10％）
編寫方案并執行實驗室儀器設備的確認和新的實驗方法的驗證。
6. Manage the Stability Program. Ensure the retention samples management meet requirements. （5％）
管理穩定性實驗計劃。確保留樣的管理符合要求。
7. Ensure all the imported material/product are sampled and analysed by BIDC according the local requirements. Maintain the file of BIDC CoAs. （5％）
確保所有進口物料及產品按照中國法規要求被北京藥檢所取樣和檢驗。保存藥檢所出具的檢驗報告書。
8. Keep close relationship and communication with other departments to ensure proper execution of the production plan. Lead and motivate the analysts for a continuous improvement of GMPs as well as HSE awareness. Be the Safety contact for the Laboratories. （5％）
與相關部門保持密切聯系和溝通以確保生產計劃的執行。領導并激勵實驗室人員不斷改進和完善GMP和環境/健康/安全程序。作為實驗室安全事務聯絡人。
9. GAP analysis for global requirement and local regulatory and take CAPA actions. Contribute to internal & External inspections （5％）
總部要求及本地法規標準的差距分析并采取必要的糾正預防措施。接受內外部審計的工作。
10. Support the new Project, eg. Product launch related QC work（10%）
服務于新的項目，例如產品上市相關的質量控制內容。
11. 理化實驗室主管HSE職責：
? 對實驗室HSE工作負直接管理責任，將HSE工作計劃納入工作計劃中。
? 組織對調換崗位人員、重新上崗人員進行HSE培訓和教育，新員工進行部門級和崗位級HSE教育；
? 定期開展本部門HSE隱患排查治理工作，并做好記錄；落實隱患整改，保證實驗設備、安全設備、消防設施、防護用具和急救器具等處于完好狀態。
? 對實驗室發生的安全、環保、職業健康事故及時報告和處理，要堅持事故原因調查不清不放過、職工不受到教育不放過、有關責任者未受處理不放過、防范措施未實施不放過的“四不放過”原則；注意保護現場，查清原因，分清責任，落實事故防范措施和對事故的責任者的處理意見。
? 參加每天+QDCI會議，監督本部門+QDCI是否有效開展。
? 組織各項HSE活動，總結交流HSE經驗，表彰先進班組和個人。
12. Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
賽諾菲（北京）制藥有限公司能源方針：“以藥品質量為第一要務，通過技術手段，行為規范，人為意識，不斷降低產品價值中的能耗比重，造福廣大用戶，促進企業發展”要求每位員工具有良好的節能意識，積極的節能行動，協助能源管理體系的持續開展
? Actively propose energy-saving projects
積極提出節能方案
? Coordinate and support the development of energy-saving projects and give positive feedback
協調并支持節能項目的制定，積極反饋意見
? Coordinate and participate in the implementation of energy-saving projects
協調并參與節能項目的執行
? Participate in internal audit of energy management system
參與能源管理體系的內部評審
職位要求：
A degree in Chemistry, Pharmacy and Biology or other related disciplines and a minimum of 4 years experience in analytical methodologies as HPLC, GC, TLC, etc.
化學、藥學和生物或相關專業學士學位，至少4年以上分析工作經驗，會使用HPLC、GC、TLC等分析儀器。
Must be problem solving oriented. Good English writing and spoken as well as a good knowledge of Chinese and international GMP are required.
須具備善于解決問題的能力和主動性。英語說、寫良好。要求了解中國和國際GMP要求。
在如下領導力方面具有較為成熟的能力
1. Sets clear direction & aligns team & others around common objectives
設定明確的方向，與團隊一起為共同的目標達成一致
2. Energizes the team 激勵團隊
3. Display passion 展現激情
4. Exercises good judgment & drives change for competitive advantage運用良好的判斷力，推動變革
5. Drives for superior results & has passion to win
追求卓越，有贏的熱情
6. Builds the talent pipeline and develop others 搭建人才發展梯隊發展團隊
7. Inspires continuous improvement & breakthrough thinking,display analytical &conceptual thinking.
鼓勵持續性改進和突破性思維，展示分析性和概念性思維能力
8. Good communication
良好的溝通能力
9.Able to burden pressure, result driven
能夠耐受壓力，結果導向。
