Summary
~管理责任范围内的质量方面和项目。
~确保并支持整体GxP合规性和诺华质量管理体系的合规性。
About the Role
Major Accountabilities
~ 监督所有生产和测试活动,确保符合cGxP,包括数据完整性和电子合规性
~ 支持异常调查
~ 审查和批准生产、质量控制以及 AS 和 T 记录
~ MBR审查
~ 支持运营支出改善项目
专业人员-根据注册执行批放行
~ 收到后 24 小时内报告与诺华产品相关的技术投诉/不良事件/特殊情况
~ 营销样本的分发(适用)
Key Performance Indicators
~管理责任范围内的质量方面和项目。
~确保并支持整体GxP合规性和诺华质量管理体系的合规性。
Work Experience
~在制药工业/生物技术领域从事环境监测和清洁区的QC/QA工作
~职能广度
~跨界协作
Skills
~技术智能
~QA(质量保证)
~GMP程序
~质量标准
~质量控制 (QC) 测试
~处理歧义
~自我意识
~持续学习
~技术专长
Language
英语
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