Responsibility: 85 Complete the tasks assigned by the leader to ensure that the current goals are achieved完成领导交给的工作任务,确保目前目标达成 85 Responsible for the internal coordination of finished product production department, such as efficient communication with ENG,FM,QA and timely problem solving;负责处理成品制剂生产部内部协调工作,例如与ENG,FM,QA之间的高效沟通以及问题及时解决; 85 Responsible for handling deviation investigation, change, CAPA and other work in the daily preparation production process;负责处理日常制剂生产过程中发生的偏差调查,变更,CAPA等工作; 85 Review production batch records in a timely及时审核生产批记录; 85 Responsible for the training and qualification confirmation of the personnel of the preparation production department, to ensure that the personnel of the department have the relevant qualifications before the production operation负责制剂生产部门人员的培训以及资质确认,确保部门人员进行生产操作前具备相关资质; 85 Cooperate with relevant development departments to complete process verification and technology transfer;配合相关开发部门完成工艺验证和技术转移; 85 Audit responsibilities, responsible for the comprehensive audit of any customer, including on-site audit and finding responses and action item tracking;审计职责,负责任何客户的全面审计,包括现场迎审以及finding的回复以及行动项跟踪; 85 Lean production requirements of the current production line, ensure the efficient utilization of the production line, and conduct risk assessment;对于目前产线的精益生产要求,确保生产线高效利用,对于产品并线,共线进行风险评估; 85 For the lean production requirements of the current production line, ensure the efficient utilization of the production line, and conduct risk assessment.管理系职责,管理项目组日常运营要求,带领团队完成直线领导赋予的工作职责。 Qualification: 85 College degree or above, more than 5 years of pharmaceutical production experience 大专以上,5年以上的制药生产经验,从事大分子领域或其他无菌制剂生产行业 85 Management experience with 3-5 employees 管理经验有3-5人员工经验 85 Familiar with biological medicine, chemical aseptic filling process, inspection, packaging and other work 熟悉生物药,化药无菌灌装工艺,检验,包装等工作 Give priority to: New product launch, commercial production experience is preferred; FDA,EMA, Chinese GMP on-site experience is preferred;