北京安必奇生物科技有限公司
CMC质量保证（QA）总监
Skills
1 day ago
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Important information
Contract type:
Permanent
Salary:
CN¥50,000 – CN¥80,000 / month
Location:
Beijing, China
Work mode:
Onsite
Published on:
24 October 2026
What they need
该职位来源于猎聘 岗位职责 1. 建立并维护GLP/GCP/GMP（GCLP）质量体系，覆盖药物物质、药物产品、分析、标签与临床供应 2. 制定并执行内部审计、CRO/CDMO监管与质量事件管理，确保合规 3. 审核批记录与合规文件，支持卫生监管部门检查与申报 4. 推动质量体系持续改进，培训跨职能团队合规意识 任职要求 1. 药学/化学/生物等相关专业硕士以上 2. 5–8年以上制药QA/QC经验，精通cGMP、ICH、FDA/EMA监管要求 3. 在大型药企或头部CRO/CDMO完整做过QA/QC与监管对接 4. 熟悉放行测试方法（HPLC/ELISA/PCR等）与数据完整性，中英文流利
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