职责描述:1. Assist the project team to draft the risk assessment of " new product a multiproduct manufacturing facility".
协助项目组起草《引入新产品至多品种生产工厂》的风险评估。
2. Responsible fthe development execution of new product cleaning verification/ validation program.
负责新品种清洁确认/验证程序的开发和执行。
3. Develop deliver effective skill building training plans fa given operational technology (i.e., cleaning sampling) to manufacturing technicians. maintain the technical training program personnel certification process. Train certify manufacturing personel on cleaning sampling.
为生产技术员开发和交付给定操作技术(例如 清洁和取样)的有效技术构建和培训计划。创建和维护技术培训计划和人员认证程序。培训和认证清洁和取样生产人员。
4. Join problem analysis sessions in support of manufacturing events.
参加支持生产事件的问题分析会议。
5. Authinvestigation summaries identify implement CAPA.
编写调查摘要和确认和执行CAPA。
6. AuthGMP documents (i.e., deviations, change controls, SOP, workder).
编写GMP文件(例如,偏差,变更控制,SOP和工作指令)
7. Provide guidance direction on cross-functional training initiatives.
为跨功能培训活动提供指导和方向。
8. Provide appropriate support factivities related to cleaning process that occurred after the cleaning validation batch.
对发生再清洁验证批次之后的有关清洁工艺的活动,给予适当的支持。
任职要求:
Minimum 3 years working experience on R&D, scale up, manufacturing
至少三年研发,放大,生产的经验
Minimum 2 years working experience on cleaning validation.
至少两年清洁验证工作经验。