Calibration Engineer 校验工程师
主要职责:
1. Support the validation if any system/equipment calibration required.
为系统/设备在验证过程中提供校准支持
2. Management of specialist contractors and vendors to calibrate equipment.
管理专业供应商和服务商对设备的校验
3. Management calibration schedules and Work Orders to document execution of calibration activities.
统筹管理涉及校验工作的计划及工单,并做好记录
4. Preparing and managing the schedule of calibration activities. Preparing and managing the register of critical instruments.
编制和管理校验工作计划表,编制和管理关键仪器的评估造册工作
5. Documenting calibration requirements for critical instruments and systems in collaboration with system users.
与用户一起制定关键仪器与系统的校验要求
6. Preparing calibration reports and status indicators.
编制校验报告和状态信息
7. Maintain Calibration SOP/National Standard: Maintain calibration SOPs to ensure that calibration activities in compliance with relevant company policies and regulatory guidelines. Follow up the National Standards updating and ensure that the calibration work of the company meets the requirement of the regulations.
维护校准SOP/国家规程:维护校准SOP以确保校准执行活动符合有关公司政策和法规要求。及时掌握国内计量法规的要求与变化,并确保本公司计量工作符合法规要求。
8. Preparing standard operating procedures and associated records for management and execution of the calibration program.
编制用于管理和执行校验程序标准操作程序和辅助记录
9. Raising and/or resolving investigations for quality incidents related to calibration of facilities and equipment.
上报或参与解决调查关于设施设备校验的质量事件
10. Reviewing instrument specifications for compliance with company quality standards and performance criteria.
复核仪表的规格标准满足于公司质量标准和仪器性能标准
11. Selecting and supervising of specialist contractors and vendors.
选择和管理专业供应商和服务商
12. Budget the annual calibration expenditure and be responsible to control the consume within the budget.
制定年度校准预算并负责校准费用使用在预算内
13. Preparing standard operating procedures and associated records for management and execution of the maintenance program.
制定操作规程,管理相关记录,执行维修程序
14. Promote cGMP compliance within the workplace by following cGMP procedures. Incorporate cGMP and regulatory compliance into all work practices.
通过遵循cGMP程序,促进工作场所内的cGMP的符合性。把cGMP和法规符合性,纳入所有的工作实践中。
15. Expected to be an effective communicator of ideas, project goals and results. With minimal supervision, is expected to make presentations and updates to senior management.

此岗位应该积极地沟通和交流想法、项目目标和结果。在最少监督的情况下,主动向高层管理进行工作和情况汇报。

任职要求:
1. Bachelor in safety/environmental/chemical/pharmaceuticals related
安全工程/环境保护类/生物化学类/制药工程等相关专业学士学位
2. Minimum of 5 years of experience in calibration within pharmaceutical or medical device industries. Or at least 8 years of industry experience in calibration in pharmaceutical, medical device, healthcare, or food industries.

至少5年药厂或医疗器械企业校验经。或不少于8年在药厂,医疗器械,医疗或者食品企业校验相关的经验

招聘人数:1