职位描述
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职位职能:
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职位描述:
Responsibilities
工作职责
1. Make up yearly training plan of Engineering Department. Monitor and coordinate other supervisors to implement their training tasks.
制定工程部年度培训计划, 监督、协助其他主管完成各自的培训任务
2. Be in charge of GMP management of Eng. Dept. and ensure the development of Eng. GMP in order and standard.
负责工程部GMP管理工作，确保工程部GMP工作有序、规范地进行
3. Be in charge of DQ/ IQ/OQ of production equipment and facilities. Work out protocol of DQ/IQ/OQ of each equipment or facility. Coordinate relevant supervisor of Eng. Department to finish data of protocol.
负责生产设备、动力设施设计安装确认和操作确认工作编制设计，安装确认和操作确认方案，协调工程部各主管按方
案完成相关数据
4. Draft the foreign oriented corresponding and communicate with the service depts. of the equipment suppliers from outside China for advice or instruction to solve the problems with the relevant machine. Technical support to the first line in the maintenance team
起草工程部的对外电文，与国外厂商联系，取得解决有关设备技术问题方面的指导性意见,做到生产一线的技术支持
5. Be in charge of CAR application .
负责公司固定资产申请流转
6. Be in charge of inquiry, analysis and justification of the imported and local equipment in the early period of purchasing.
进口及国产生产设备前期调研报价，分析及申请理由
7. Follow up imported equipment delivery condition, be in charge of sending testing samples to supplier for test, and communicate the relevant persons to finish Factory Acceptance Test before equipment delivery and get test report.
跟踪进口设备的到货情况，负责将试车材料寄给设备供应商，联系相关人员完成设备工厂验收测试并得到报告
8. Be in Charge of installation, debugging and adjustment, trial and validation of new local-made and imported pharmaceutical equipment. Coordinate the progress schedule, and assist foreign experts to carry on the installation, debugging and adjustment of equipment and finish qualification report.
负责国产、进口新制药设备的安装、调试、试运行、验证，进行进度协调，协助外国专家搞好安装调试，并出具验证报告
9. Complete other assignments given by superior
完成领导其他交办任务
Qualification Requirements
岗位要求
1. 2 years or above work experience of equipment management in pharmaceutical plant
二年以上药厂设备管理工作经验
2. Familiar with GMP requirements for equipment, instrument and process.
熟悉药厂GMP对设备、仪表和工艺的要求
3. Bachelor degree or above, major in Mechanical Engineering, Equipment or Instrument
具有机械、设备、仪表等工科类大学本科以上
4.CET- 4 or above, have an excellent ability to listen, speak, read and write in both English and Chinese
英语四级或以上,具有良好的中英文听说读写能力
5. Knowledge of IQ/OQ documentation
了解IQ/OQ文档编辑
6. Knowledge of all kinds of manufacturing equipment, utility equipment and other equipment.
了解各类生产设备、动力设备及其它现场设备
7. Knowledge of GMP, EHS
理解GMP规范，了解EHS知识
8. Ability of people management
具备有相关的管理领导能力
9. Ability of planning spare parts according to the importance of equipment
具备根据设备的重要性，提出备件计划的能力
10. Ability to use MS Office
具备使用办公室软件的能力
