岗位描述
负责进行上游细胞培养的所有生产活动(如细胞复苏和摇瓶传代,一次性生物反应器细胞培养,细胞发酵液收获等)并确保批生产活动符合当前 GMP 要求
Responsible for upstream process to ensure and complete batch production activities(Vial thaw and cell suspension in shake flask, Cell culture in single use bioreactor, Cell culture material harvest) under cGMP compliance.
在有限的指导下能够独立执行生产项目并领导员工按计划完成生产任务
Under limited supervision, can independently coordinate the execution of projects and lead operations to accomplish production on schedule.
负责按GMP要求进行洁净区内的清洁消毒工作,如周期清洁、清场清洁和设备表面清洁等。
Be responsible for cleaning in the clean area per GMP requirement, such as periodic cleaning, changeover cleaning and equipment cleaning, etc.
负责SOP/MBR/URS/FAT/SAT等文件的起草/升版。
Be responsible for drafting/revising SOP/MBR/URS/FAT/SAT or other documents.
负责配合部门对其他有需求的员工进行相关培训,并按时完成个人的培训任务。
Be responsible for training or coordinating training, and maintaining individual training record on time.