岗位描述
岗位职责
负责按GMP要求进行细胞扩增、细胞培养、深层过滤等生产工艺操作。
Be responsible for cell expansion, cell culture, depth filtration and other process operation per GMP requirement.
负责GMP文件包括但不限于SOP/MBR/URS/FAT/SAT/IOPQ等文件的起草/升版。
Be responsible for drafting/revising GMP documents, including but not limit SOP/MBR/URS/FAT/SAT/IOPQ or other documents
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.
参与相关变更,偏差的调查执行,以及审计整改活动计划的执行。
Involving in the initiation and investigation of deviation, initiation and execution of change control, and implementation of CAPAs including audit findings.
负责配合部门对其他有需求的员工进行相关培训。
Be responsible for training or coordinating training.
及时完成培训,按GMP的要求有资质执行所需操作。
Can be trained in time and qualified to perform the operation per GMP compliance.
主动开展业务优化并持续改进。
Take initiative to optimize the operation and continuous improvement.
任职要求:
本科以上学历,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。
Bachelor degree (or above) with major in Biology, Chemistry or Pharmaceutical Engineering or related Science major or person with equivalent experiences.
有2年及以上GMP工作经验。
Have two years or above experience in GMP production is preferred.
具有较好的沟通能力和理解能力。工作积极向上并具有良好的学习能力。
Have good communication and understanding ability.
工作积极向上并具有良好的学习能力。
With an optimistic work attitude and good learning ability.