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Apr 15, 2021
  • 建立生产支持组溶液配制、文件管理、器具准备的岗位职责
  • Establishing job responsibility of Solution Preparation,Document Management , Tubing / Components Preparation and Material Management for MFG1-PS.
最低任职要求Minimum Requirement
  • 教育程度/经验Education background/ Experience
  • 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。
  • Junior college degree (or above) with major in Biology, Chemistry or Pharmaceutical Engineering or related Science major or person with equivalent experiences.
特别知识Special knowledge
  • 具有培养基/缓冲液配制等GMP生产操作的相关知识或经验,有2年及以上工作经验者优先。
  • Knowledge in GMP production about media/buffer preparation, etc, and with two years or above experience is preferred.
  • 具有较好的沟通能力和理解能力。
  • Ability to communicate and understand well.
  • 其他要求(比如工作时间等)Other requirements (e.g.: working time)
  • 具有吃苦耐劳的品质及良好的身体素质。
  • Must be hard working and physically fit the job (must have the ability to lift a minimum of 15kg).
  • 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.
  • 领导员工按计划完成生产任务并确保批生产活动符合当前GMP的要求。
  • Lead operators to accomplish production on schedule, and ensure to complete batch production activities under cGMP compliance.
  • 确保组内成员及时完成培训,按cGMP的要求有资质执行所需操作。
  • Responsible for ensuring all subordinates training up to date, and qualified to perform the operation per cGMP compliance.
  • 负责维护GMP车间的安全运行状态,进行组内员工的安全教育及监督。
  • Keep a safe environment in cGMP facility. Responsible for the safety education and supervision.
  • 及时向领导反馈工艺、人员、安全、生产环境、维护及其他问题。
  • Communicate status of process, personnel, safety, environment, maintenance and other issues, in a timely manner to his/her director.
  • 起草审阅GMP文件,包括但不限于SOP/MBR/URS/FAT/SAT,审核批生产记录。
  • Author and review GMP documents including, but not limited to SOP/MBR/URS/FAT/SAT, as well as review the executed batch record.
  • 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。
  • Responsible for training or coordinating training, and maintaining oneself training record current.
  • 负责按GMP要求进行器具准备、培养基/缓冲液配制等生产工艺操作。
  • Responsible for instrument preparation, media/buffer preparation and other process operation per GMP requirement.
  • 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。
  • 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.
  • 负责指导并发展下属员工,领导团队建设。
  • Responsible for mentoring and developing subordinates and build a strong team.
  • 主动开展业务优化并持续改进。
  • Take initiative to optimize the operation and continuous improvement.
  • 负责组内及部门的日常管理事务。
  • Responsible for the routine group and department administrative affairs.