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QA经理

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Onsite

QA经理

上海凯莱英生物技术有限公司

QA经理

Skills

Testing & QA

1 year 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 岗位职责: 1. 复核/批准产品生产相关变更.偏差.OOS/ATR等GMP文件;参与或组织重大偏差/客户投诉调查,并分析根本原因及纠正预防措施; 2. 复核/批准产品生产操作记录,设备清洗方案等项目文件,对生产现场巡查并复核/核实操作的合规性; 3. 复核/审批产品生产相关的验证计划,工艺/清洁验证方案及报告,工艺规程等,参与并监督工艺及设备相关验证活动的执行; 4. 监督终产品的洁净操作,包括产品分离,干燥,粉碎,混料,包装等开放性操作; 5. 复核设备记录,包括设备清洗记录.设备状态记录和清场记录,对设备的清洁和清场确认,房间或区域的清场确认; 6. 对接客户审计/内部审计等相关工作; 7. 执行质量回顾(如产品年度回顾)和趋势分析。 任职要求: 1、海归硕士学历,有QA相关工作经验,有团队管理经验者优先; 2、有良好的组织沟通和协调管理能力,以及团队合作意识和大局观念,思路清晰; 3、英语可以作为工作语言。

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