ngs安评合规服务运营经理(cgt药物安全评价服务) - Suzhou City

仅限注册会员 Suzhou City, 中国

1个月前

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该职位来源于猎聘 1. 在公司战略的方向下,协助公司领导实现NGS相关药企检测业务的建立和整体经营目标; 2. 基于当前大分子药物,细胞和基因药物研发生产过程中检测需求,开发新的检测项目; 3. 运营维护NGS合规检测实验室,交付检测项目,并协助客户进行相关审计,IND及后期的相关申报; 4. 建立及维护实验室的CNAS,CMA认证,并通过检查与审查与中国药监局/FDA等部门保持信息对等; 5. 通过与客户合作进行不合规,不合格事件,包括OOS,偏差和CAPA的调查,通过数据分析和临时程序控制持续监控有效性; 6. 代表AZENTA与政府,公司相关机构建 ...
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