验证qa经理 - Shanghai

仅限注册会员 Shanghai, 中国

1个月前

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该职位来源于猎聘 岗位职责: 1. 参与计算机化系统管理程序的建立,确保计算机化系统在放行前前按照风险评估的结果进行了合适的验证且在上线后始终保持验证状态; 2. 参与生产设备的概念设计、详细设计、风险评估、URS、设计审核、FAT 和SAT 等活动; 3. 参与厂房设施、公用系统、仪器设备和计算机化系统的确认、验证工作,审核、批准相关文件审核; 4. 审核、批准验证文件并参与验证过程中问题的调查分析及变更的评估,确保系统、软件、设备在放行前满足质量和合规要求; 5. 审核、批准工艺验证、清洁验证、分析方法确认/验证文件,确保满足质量和合规要求; 6. ...
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