锦鲤求职岗位描述
1. 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。
2.其他要求Other requirements
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3年及以上管理经验者优先。 Knowledge in GMP production about media/buffer preparation, etc, and with three years or above experience is preferred。
熟练掌握配液相关设备的使用。 Proficient in the use of related equipment in the solution preparation group.
具有优秀的沟通表达能力，以及良好的口头和书面英语水平。 Good communication and presentation skills, as well as good at both oral and written English.
具有吃苦耐劳的品质及良好的身体素质（至少提起15Kg的重物）。 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.
3.工作职责JOB RESPONSIBILITY
负责进行生产支持的所有生产活动并确保批生产活动符合当前GMP的要求。 Responsible for all Production Support activities to ensure to complete batch production activities 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 operators to accomplish production on schedule.
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.
启动偏差，领导调查工作、变更实行及纠正和预防措施的执行。 Initiate deviations, lead investigations, execution of change control and implementation of CAPAs.
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.
负责生产物料采购、跟踪、管理、监管物料供应状态，必要时与供应商或经销商等沟通联系。 Responsible for material ordering, tracking, management and inventory status. Contact suppliers and vendors as required.
与工程或相关部门沟通协调设备厂房的维护维修及计量工作。 Communicate and coordinate equipment and facility maintenance and metrology needs to Eng or other Deparment.
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.
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.