GMP體系QC合規(guī)與驗(yàn)證專家（英文好）
2元以上
北京
3年以上
本科
北京
3年以上
本科
- 全勤獎(jiǎng)
- 節(jié)日福利
- 不加班
- 周末雙休
2025-09-30 05:04:03
602人關(guān)注
職位描述
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Job title職位名稱:
61QC專家-QC驗(yàn)證與合規(guī)專家
61 Beijing 北京
61制造與供應(yīng)事業(yè)部
職責(zé)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(shí)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(cè)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(rèn)方案/報(bào)告及分析方法驗(yàn)證，并進(jìn)行相關(guān)驗(yàn)證工作；
4. Ensure training management compliance and meet lab business needs
確保培訓(xùn)管理流程合規(guī)符合實(shí)驗(yàn)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(biāo)準(zhǔn)進(jìn)行理化實(shí)驗(yàn)，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(shí)檢驗(yàn)。執(zhí)行實(shí)驗(yàn)室調(diào)查以及產(chǎn)品質(zhì)量評(píng)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(shí)驗(yàn)室工作經(jīng)驗(yàn)，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(dòng)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(guó)和國(guó)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(xué)、生物化學(xué)、微生物學(xué)、藥學(xué)等相關(guān)專業(yè)學(xué)士及以上學(xué)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(yàn)證與合規(guī)專家
61 Beijing 北京
61制造與供應(yīng)事業(yè)部
職責(zé)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(shí)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(cè)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(rèn)方案/報(bào)告及分析方法驗(yàn)證，并進(jìn)行相關(guān)驗(yàn)證工作；
4. Ensure training management compliance and meet lab business needs
確保培訓(xùn)管理流程合規(guī)符合實(shí)驗(yàn)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(biāo)準(zhǔn)進(jìn)行理化實(shí)驗(yàn)，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(shí)檢驗(yàn)。執(zhí)行實(shí)驗(yàn)室調(diào)查以及產(chǎn)品質(zhì)量評(píng)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(shí)驗(yàn)室工作經(jīng)驗(yàn)，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(dòng)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(guó)和國(guó)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(xué)、生物化學(xué)、微生物學(xué)、藥學(xué)等相關(guān)專業(yè)學(xué)士及以上學(xué)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(shí)，請(qǐng)說是在寧夏人才網(wǎng)上看到的。
工作地點(diǎn)
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(hào)
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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(hào)外企德科大廈
