上海凯莱英生物技术有限公司
固体制剂现场合规副主管
Skills
4 months ago
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Important information
Contract type:
Permanent
Location:
Tianjin, China
Work mode:
Onsite
Published on:
8 August 2026
What they need
该职位来源于猎聘 负责固体制剂车间工艺合规性的一系列事宜： 1. 固体制剂车间相关文件的起草和优化，确保车间文件体系满足cGMP要求； 2. 针对固体制剂车间生产过程中发生的偏差、变更，配合QA组织展开调查和评估，形成偏差报告调查表；如期有效的落实CAPA，跟踪CAPA有效性； 3. 参与生产现场控制过程，掌握质量情况并及时上报，督促并帮助生产一线及时解决生产中出现的技术问题； 4. 车间GMP符合性管理，车间污染、交叉污染、混淆差错等风险识别和降低措施； 5. 协助客户审计和官方审计工作； 6. 组织实施车间内部培训
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