Job title职位名称:
61QC专家-QC验证与合规专家
61 Beijing 北京
61制造与供应事业部

职责概述：1. Draft of QC related SOPs, record template. Ensure periodically reviewing QC quality system document and executing system document gap analysis.
起草QC相关SOP及记录模板，确保定期回顾QC质量体系文件，及时执行体系文件差距分析
2. Perform regulatory gap analysis and assist in drafting registration-related dossier.
执行法规的差距分析，协助撰写注册相关文件。
3. Draft qualification protocols/reports of the analytical instruments and the validation analytical methods. Perform the qualification work.
仪器确认方案/报告及分析方法验证，并进行相关验证工作；
4. Ensure training management compliance and meet lab business needs
确保培训管理流程合规符合实验室业务需求
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/标准进行理化实验，遵守良好文件记录和GMP以及环境/安全/健康的要求。
6. Ensure that analyses are carried out in time. Execute lab investigations and the quality assessment.
确保样品及时检验。执行实验室调查以及产品质量评估；

About you 任职资格:
61 Experience: Have Pharmacy GMP lab working experience more than 5 years. Proficient in operating common equipment (HPLC, GC, IR, UV, TOC...)
具有药厂5年以上GMP实验室工作经验，能熟练操作常见设备（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: 沟通，问题解决, 善于解决问题的能力和主动性。
61 Technical skill: a good knowledge of Chinese and international GMP, DI are required.
专业技能: 要求熟悉中国和国际GMP，数据完整性要求。
61 Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc. bachelor degree at a minimum
教育背景: 化学、生物化学、微生物学、药学等相关专业学士及以上学位
61 Languages: Good at English writing, reading, listening and speaking.
语言要求:英语听说读写良好
61 Play to Win Behaviors: Stretch; Take Action; Act for Patients