上海招聘

主要职责/Responsibilities:

1. 负责具体的确认/验证程序的实施和维护（如消毒剂效力、培养基灌装、设施公用工程和设备），确保与内部流程和cGMP的符合性。必要时，主导验证项目的推进。Be responsible for maintenance and implementation of dedicated qualification and validation program, and ensure compliance towards internally established procedure and cGMP. And where applicable, lead specific validation project.
2. 负责推动验证文件的生命周期的实施，确保交付物与相关规程的符合性。Be responsible for pushing forward the implementation of a validation documentation life cycle, ensure deliverables are complied with related procedures.
3. 负责维护现场与设备确认相关的标示标记，确保其处于最新状态。Be responsible for maintaining on-site labels related to qualification to an up-date-manner.
4. 负责起草与工作职能相关的SOP、管理文件。Be responsible for initiation of SOP, management document related to job responsibilities.
5. 为维护工厂验证主计划以及独立的验证分计划提供支持。Support in maintaining site validation master plan, and individual validation plan.
6. 支持确认和验证程序的实施，组织和开展内部/外部的讲习会。Support in implantation of qualification and validation program, organize and perform workshop meetings internally.
7. 为实施风险评估工作提供支持，包括但不限于初始系统评估，以及详细的系统层面的风险评估。当必要时，应与用户协作。Support in implementing a risk-based approach in JW, including but not limited to initial system assessment, and detailed systematic level risk assessment. Coordinate with end users where necessary.
8. 支持内部/外部审计和GMP检查。Support internal/external audit and GMP inspection.
9. 为质量体系的设计和执行提供支持，包括变更管理、偏差调查、CAPA和其他验证活动。Aid in the design and implementation of quality systems to support change management, deviation investigation, CAPA and other validation activities.
10. 其他由上级指定的工作任务。Perform other duties delegated by immediate supervisor.
11. 与其它团队成员合作完成确认/验证活动。Cooperation with other team member regarding qualification/validation activities.

药明巨诺是一家专注于细胞免疫治疗、处于临床阶段的创新型生物科技公司，站在巨人的肩膀上，充分结合了美国巨诺公司国际领先的技术优势以及药明康德集团强大的本土经验。

定位与愿景：
致力于以创新为先导，成为细胞免疫治疗引领者
 - 对患者：用最前沿的细胞免疫治疗技术、高品质的产品，造福中国及全球患者
 - 对行业：与国内外合作伙伴携手开展多方位合作，共建中国细胞免疫治疗的行业规范与生态系统，打造国际领先的细胞免疫治疗技术创新平台