Responsibilities: 61 按GMP要求参与上游细胞培养或微生物发酵和收获等生产工艺相关操作 Proactive to join and contribute to Upstream cell culture or microbial fermentation and harvest operations. 61 参与并执行生产项目按时完成生产计划 Execute production plan on time. 61 负责批生产记录的起草和更新以及相关生产技术文件和生产操作文件及记录的审核 Draft and review production related documents . 61 负责参与上游过程的工艺控制与风险管控 Proactive to join upstream assessment and risk mitigation. 61 负责参与方案的起草和审核、组织与实施验证 Proactive for drafting , reviewing , organizing and implementation of the protocol 61 协助上级参与内部审计,偏差调差,制定预防纠偏措施并监督各项行动的执行 Contribute to help the supervisor in audit , deviation investigation , CAPA and execution . 61 协助生产过程中流程优化及持续改善 Contribute to process optimization and sustain improvement. 61 按时完成个人GMP培训任务,保证自己有资质执行所需操作 Complete individual GMP training tasks to ensure yourself are qualified to GMP activities. 61 完成上级交待的其他相关任务 Complete other tasks assigned by supervisor.
Qualification: 61 大学本科及以上学历,生物、化学、医药工程等相关专业,或具有同等工作经验的人员 61 Bachelor or above , major in biology , chemistry or engineering . Or have the working equivalent experience . 61 有细胞培养、微生物发酵相关工作经验3年及以上 61 At least 3 years of experience on cell culture or microbial fermentation.