Job Description

**KEY RESPONSIBILITIES / DUTIES** **主要职责:**



+ Provides Engineering knowledge support to a process, project or other function. Knows and applies fundamental Engineering and Quality Management System concepts, practices and procedures.



提供工程知识,支持工艺开发、项目及其他部门,熟知质量管理系统理念,实践和流程



+ Ensure quality of process and product as defined in appropriate OS and Material specifications.



保证工艺,产品质量满足操作系统及材料规格要求



+ Ensure GMPs and system safety.



保证GMP 执行及系统安全



+ Lead PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and scale ups.



领导过程失效模式及分析, 控制计划,标准作业程序,生产批准流程生成,有关产品转移及扩展。



+ Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.



支持固定资产的投资,设备选型,合同谈判,安装验证



+ Provide training for manufacturing team members.

...

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