| 職位要求： |
Key Skills:主要技能
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Analytical Support for Generic Pharmaceutical drug Products - OSD s口服固體制劑仿制藥研發分析支持
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Planning & Execution of routine analysis in lab & report taking實驗室日常分析與制作報告的計劃和實施
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Analytical Method development & Validation as per USFDA / EU requirements按照美國FDA和歐盟的要求，進行分析方法的開發與驗證
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Multimedia Dissolution profile studies of OSD s口服固體制劑多介質溶出曲線試驗
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Stability studies planning & Execution as per regulatory requirements按照法規要求，進行穩定性研究的計劃和實施
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Thorough knowledge of qualification, operation, maintenance & calibration of analytical instruments like HPLC, GC, UV, Dissolution apparatus, Auto - Titrator, Malvern Particle Sizer, etc 熟練分析設備的確認，操作，維護和校準工作，如HPLC, GC, UV, 溶出儀, 自動滴定儀, 馬爾文激光粒度儀等
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Maintain GMP & GDP (Good Documentation practices) in the Laboratory實驗室GMP與GDP（良好文件規范）符合性維護
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Responsible for ensuring correctness & Integrity of Analytical data in the lab – CFR Part-11 負責確保實驗室分析數據的準確性與完整性，使符合CFR Part-11要求
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Waters Empower network Software administration Waters Empower網絡版軟件監管
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Professional training & development of analysts負責分析師的專業培訓與發展
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Take part in Dossier preparation (CMC part)參與申報資料的撰寫（CMC部分）
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Knowledge of Generic Pharmaceutical development process will be an added advantage 具有仿制藥研發經驗優先考慮
Education: Bachelors / Masters Degree in Pharmaceutical / Analytical chemistry
教育背景：本科或碩士學位，藥學或分析化學專業
五年以上相關研發分析經驗
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