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QA质量经理(验证方向)

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Onsite

QA质量经理(验证方向)

上海凯莱英生物技术有限公司

QA质量经理(验证方向)

Skills

Testing & QA

1 month ago

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Important information


Contract type:

Permanent

Work mode:

Onsite

Published on:

4 September 2026

What they need


该职位来源于猎聘 职责描述: 1、负责制定验证总计划及年度验证计划,确保设备验证工作的系统性和规范性‌,验证管理相关文件起草、修订及执行;

2、负责验证管理工作中偏差的发现、变更的申请与实施等相关工作;

3、参与并组织厂房、设施设备、工艺、清洁、检验仪器、检验方法等,对方案及报告进行审核;

4、负责验证计划的制定,负责年度验证报告的撰写;

5、负责设备/仪器计量年度计划的制定及年度报告撰写,负责每月计量工作的组织开展;

6、组织验证相关的专题培训及交流,提升团队的专业能力和水平‌。 任职要求: 1、本科及以上学历,制药相关专业,具备4年以上质量管理或生产管理经验,以及验证管理工作经验‌; 2、熟悉中国、EU、FDA及相关制药领域国际组织对于GMP和确认与验证方面的要求,熟悉公用系统、设备、检验仪器、工艺、清洁等验证流程‌; 3、具备良好的沟通能力、团队协作能力和逻辑分析能力,工作细致、踏实、有责任心、学习能力强‌; 上市公司,平台发展好/免费住宿/饭补/年终奖/项目奖金

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