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Job title職位名稱:
61QC專家-QC驗證與合規(guī)專家
61 Beijing 北京
61制造與供應(yīng)事業(yè)部
職責概述：1. Draft of QC related SOPs, record template. Ensure periodically reviewing QC quality system document and executing system document gap analysis.
起草QC相關(guān)SOP及記錄模板，確保定期回顧QC質(zhì)量體系文件，及時執(zhí)行體系文件差距分析
2. Perform regulatory gap analysis and assist in drafting registration-related dossier.
執(zhí)行法規(guī)的差距分析，協(xié)助撰寫注冊相關(guān)文件。
3. Draft qualification protocols/reports of the analytical instruments and the validation analytical methods. Perform the qualification work.
儀器確認方案/報告及分析方法驗證，并進行相關(guān)驗證工作；
4. Ensure training management compliance and meet lab business needs
確保培訓管理流程合規(guī)符合實驗室業(yè)務(wù)需求
5. To carry out QC analyses in compliance with analytical methods/protocols/specifications, follow good documentation practices, CGMP, safety health and environmental.
按照分析方法/方案/標準進行理化實驗，遵守良好文件記錄和GMP以及環(huán)境/安全/健康的要求。
6. Ensure that analyses are carried out in time. Execute lab investigations and the quality assessment.
確保樣品及時檢驗。執(zhí)行實驗室調(diào)查以及產(chǎn)品質(zhì)量評估；
About you 任職資格:
61 Experience: Have Pharmacy GMP lab working experience more than 5 years. Proficient in operating common equipment (HPLC, GC, IR, UV, TOC...)
具有藥廠5年以上GMP實驗室工作經(jīng)驗，能熟練操作常見設(shè)備（HPLC, GC, IR, UV, TOC……）
61 Soft skill: Communication, problem solving oriented. as well as a good knowledge of Chinese and international GMP are required.
通用技能: 溝通，問題解決, 善于解決問題的能力和主動性。
61 Technical skill: a good knowledge of Chinese and international GMP, DI are required.
專業(yè)技能: 要求熟悉中國和國際GMP，數(shù)據(jù)完整性要求。
61 Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc. bachelor degree at a minimum
教育背景: 化學、生物化學、微生物學、藥學等相關(guān)專業(yè)學士及以上學位
61 Languages: Good at English writing, reading, listening and speaking.
語言要求:英語聽說讀寫良好
61 Play to Win Behaviors: Stretch; Take Action; Act for Patients
61QC專家-QC驗證與合規(guī)專家
61 Beijing 北京
61制造與供應(yīng)事業(yè)部
職責概述：1. Draft of QC related SOPs, record template. Ensure periodically reviewing QC quality system document and executing system document gap analysis.
起草QC相關(guān)SOP及記錄模板，確保定期回顧QC質(zhì)量體系文件，及時執(zhí)行體系文件差距分析
2. Perform regulatory gap analysis and assist in drafting registration-related dossier.
執(zhí)行法規(guī)的差距分析，協(xié)助撰寫注冊相關(guān)文件。
3. Draft qualification protocols/reports of the analytical instruments and the validation analytical methods. Perform the qualification work.
儀器確認方案/報告及分析方法驗證，并進行相關(guān)驗證工作；
4. Ensure training management compliance and meet lab business needs
確保培訓管理流程合規(guī)符合實驗室業(yè)務(wù)需求
5. To carry out QC analyses in compliance with analytical methods/protocols/specifications, follow good documentation practices, CGMP, safety health and environmental.
按照分析方法/方案/標準進行理化實驗，遵守良好文件記錄和GMP以及環(huán)境/安全/健康的要求。
6. Ensure that analyses are carried out in time. Execute lab investigations and the quality assessment.
確保樣品及時檢驗。執(zhí)行實驗室調(diào)查以及產(chǎn)品質(zhì)量評估；
About you 任職資格:
61 Experience: Have Pharmacy GMP lab working experience more than 5 years. Proficient in operating common equipment (HPLC, GC, IR, UV, TOC...)
具有藥廠5年以上GMP實驗室工作經(jīng)驗，能熟練操作常見設(shè)備（HPLC, GC, IR, UV, TOC……）
61 Soft skill: Communication, problem solving oriented. as well as a good knowledge of Chinese and international GMP are required.
通用技能: 溝通，問題解決, 善于解決問題的能力和主動性。
61 Technical skill: a good knowledge of Chinese and international GMP, DI are required.
專業(yè)技能: 要求熟悉中國和國際GMP，數(shù)據(jù)完整性要求。
61 Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc. bachelor degree at a minimum
教育背景: 化學、生物化學、微生物學、藥學等相關(guān)專業(yè)學士及以上學位
61 Languages: Good at English writing, reading, listening and speaking.
語言要求:英語聽說讀寫良好
61 Play to Win Behaviors: Stretch; Take Action; Act for Patients
注：聯(lián)系我時，請說是在江蘇人才網(wǎng)上看到的。
工作地點
地址：北京大興區(qū)賽諾菲(北京)制藥有限公司大興區(qū)興盛街7號
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詳細位置，可以參考上方地址信息
求職提示：用人單位發(fā)布虛假招聘信息，或以任何名義向求職者收取財物（如體檢費、置裝費、押金、服裝費、培訓費、身份證、畢業(yè)證等），均涉嫌違法，請求職者務(wù)必提高警惕。
職位發(fā)布者
張壽紅HR
北京外企德科人力資源服務(wù)上海有限公司
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專業(yè)服務(wù)
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1000人以上
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中外合資（合資·合作）
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中山南路589號外企德科大廈
