职位描述
岗位描述
Job Description
1. 在GMP车间内参加免疫细胞产品的生产操作,以及生产准备和清场活动;
Participate in production operation of cell products in GMP facility, as well as production preparation and clearance activities;
2. 参与生产工艺的开发,优化和技术转移等工作;
Participate in production process development, optimization and technology transfer.
3. 起草生产相关的工艺操作SOP文件和流程管理SMP文件等;
Draft the documents of process operation SOP and process management SMP related to the production;
4. 支持质量系统相关的风险评估和控制,包括偏差调查,预防纠正措施和变更控制;
Support the risk assessment and control related quality system, including deviation investigation, preventive corrective action an…