岗位职责：
1. Primary responsibilities: Design and conduct the Process Validaton, including
risk assessment of process control points, evaluation of development history, validation
program for new products, continously improvement program for existing process.
首要责任：设计和进行工艺验证，包括工艺控制点风险评估，发展史评估，新产品验证计划，现有工艺持续改进计划。
2. Join problem analysis sessions in support of manufacturing events
参加支持生产事件的问题分析会议。
4. Author investigation summaries and identify and implement CAPA.
编写调查摘要并确认和执行CAPA。
5. Author GMP documents (i.e., deviations, change controls, SOP, and work order)
编写GMP文件（例如，偏差，变更控制，SOP和工作指令）
6. Provide support product lifecycle management.
7. Primary responsibilities supporting Cleaning Validation will include development and execution of cleaning verification/validation program for new products, overseeing requalification program for existing equipment/facilities, implementation of new cleaning technologies and approaches, and authorizing cleaning monitoring trend reports.
支持清洁验证首要责任将包括新产品清洁确认/验证计划的开发和执行，现有设备/设施再确认计划的监管，新清洁技术和方法的执行和编写清洁监控趋势报告。
8. Develop and deliver effective skill building and training plans for a given operational technology (i.e., cleaning and sampling) to manufacturing technicians. Create and maintain the technical training program and personnel certification process. Train and certify manufacturing personel on cleaning and 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。
9. Join problem analysis sessions in support of manufacturing events
参加支持生产事件的问题分析会议。
10. Author investigation summaries and identify and implement CAPA.
编写调查摘要和确认和执行CAPA。
11. Author GMP documents (i.e., deviations, change controls, SOP, and work order)
编写GMP文件（例如，偏差，变更控制，SOP和工作指令）
12. Provide guidance and direction on cross-functional training initiatives.
为跨功能培训活动提供指导和方向。