质量管理经理(QA Manager) - Suzhou City

仅限注册会员 Suzhou City, 中国

1个月前

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该职位来源于猎聘 岗位职责: 1. · 负责对产品过程进行监督控制,对批生产记录进行评估。 2. 组织和监控生产区、QC实验室、库房和动力系统区域的 GMP 活动,确保符合 GMP 要求和己批准的 SOP 要求。 3. 负责原辅料、包装材料、GMP生产用耗材、中间产品的审核批准,确保、经过检验,并符合经注册批准的要求和质量标准,在物料批次放行时所有偏差或 OOS 己被正确处理。 4. 负责审核产品批记录,确保在产品放行前完成批记录的审核。 5. 对变更和偏差进行管理、调查、跟踪。召回处理、与客户投诉相关的质量问题的调查与跟踪,质量相关的 CAPA 追踪。 ...
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