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制剂灌装项目工程师
1-1.5万
人 · 大专 · 3年及以上工作经验 · 性别不限2025/03/06发布
培训

苏州工业园区

低价好房出租>>

东旺路五号

公司信息
康日百奥生物科技(苏州)有限公司

合资/150-500人

该公司所有职位
职位描述
Responsibility:
85 Complete the tasks assigned by the line leader to ensure that the current goals are achieved 完成直线领导交给的工作任务,确保目前目标达成
85 Resp for the internal coordination of the finished product production department according to the arrangement of the line leader, such as efficient communication with TS,FM,QA and timely problem solving; 根据直线领导安排工作处理成品制剂生产部内部协调工作,例如与TS,FM,QA之间的高效沟通以及问题及时解决;
85 Responsible for handling deviation investigation, CR 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 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 Take as an internal planner to track and confirm production according to production tasks, and coordinate production scheduling in time; 作为内部计划员根据生产任务对生产进行进行跟踪确认,并及时协调排产工作;
85 Department materials preparation, procurement work;部门生产相关物品准备,采购申请工作;
85 Assist FF&ENG to complete the corresponding coordination work;协助FF&ENG完成相应协调工作;
Qualification:
85 College degree or above, more than 3 years of pharmaceutical production experience;大专以上,3年以上的制药生产经验,从事大分子领域
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;
优先考虑:
新品上市,商业化生产经验优先;
FDA,EMA,中国GMP现场迎审经验优先;

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