Job title職位名稱:
61QC專家-QC驗證與合規專家
61 Beijing 北京
61製造與供應事業部

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SOP及記錄模板
，確保定期回顧QC質量體係文件，及時執行體係文件差距分析
2. Perform regulatory gap analysis and assist in drafting registration-related dossier.
執行法規的差距分析，協助撰寫注冊相關文件。
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，並進行相關驗證工作
；
4. Ensure training management compliance and meet lab business needs
確保培訓管理流程合規符合實驗室業務需求
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。執行實驗室調查以及產品質量評估；

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實驗室工作經驗
，能熟練操作常見設備（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, 善於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.
專業技能: 要求熟悉中國和國際GMP
，數據完整性要求。
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、藥學等相關專業學士及以上學位
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