Job Description
Work Flexibility: Onsite Provides Engineering knowledge support to a process, project or other function. Knows and applies fundamental Engineering and Quality Management System concepts, practices and procedures. Ensure quality of process and product as defined in appropriate OS and Material specifications. Ensure GMPs and system safety. Lead PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and scale ups. Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. Provide training for manufacturing team members. Interface with Materials Science, Design and Quality Assurance departments to provide customer wit...
KEY RESPONSIBILITIES / DUTIES主要职责:
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
保证工艺，产品质量满足操作系统及材料规格要求
保证GMP 执行及系统安全
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。
支持固定资产的投资，设备选型，合同谈判，安装验证
为生产团队提供培训
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