Job opening - QA 经理（生物制品） in 常州市
【主要职责】 1.制定并推动公司质量方针、质量目标的实施，负责维护整体质量体系的持续有效运行。主持管理评审，向最高管理层报告质量体系运行绩效、风险和改善机会。 2.作为公司与药监部门(NMPA，WHO，FDA等)进行GMP相关沟通的主要对接人之一，主导应对国内外监管机构及客户的GMP审计，策划并组织公司内部GMP自查(自检)计划，跟踪整改措施的落实。 3.确保关键工艺步骤得到有效监督，所有生产和检验活动符合批准的工艺规程和SOP。 4.负责全公司偏差(00S/00T/00E等)、投诉、退货的调查、处理及根本原因分析的系统管理主导变更控制系统的执行，评估变更对产品质量、安全性、有效性和法规符合性的潜在影响。推动纠正与预防措施(CAPA)系统的有效运行，...
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