Job opening - QA 高级经理 in 杭州市
【岗位职责】 1、质量体系搭建与运维（核心） •独立搭建适配CGT行业、适配租赁GMP场地自主生产模式的全套CT-GMP质量体系，包含质量手册、程序文件、SOP、记录体系、数据完整性体系、变更/偏差/OOS/CAPA闭环管理体系。 •建立完善供应商质量管理体系，完成原辅料、耗材、检测服务、场地供应商的审计、准入、评估与年度复盘，搭建合格供方清单（AVL）。 •主导公司内审、管理评审、年度质量回顾，持续优化质量体系，规避审评及核查风险。 2、跨主体质量管控（场地租赁模式专属） •负责与CXO供应商等GMP场地方对接，签订场地租赁质量协议，清晰划分双方质量权责、场地管理责任与产品质量责任边界。 •搭建双体系融合接口文件，统筹跨主体变更同步、场地设备/环境...
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