(Sr.)F&E Management Manager (高级)设施设备管理经理
主要职责:

1. Prepare, review and update documented User Requirement, Functional Specifications, and Detailed Specifications.
准备、审核和更新用户需求,功能规格和详细规格表。
2. Write and update the SOPs related to management of equipment (e.g. System ID, system validation status) and provide the training to the users.
编制及更新设备管理相关的SOP(例如系统ID、 系统验证状态等)并给用户进行培训。
3. Generate the equipment maintenance plan and establish the process equipment Maintenance Master Schedule.
针对设备建立维护计划且形成维护主计划。
4. Critically assess spare parts requirement to generate the purchase list of the safety stock. If any shortage after consumption, reorder the parts.
对设备进行备件关键性评估,根据评估结果建立安全库存。使用消耗后,及时进行采购。
5. Ensure department GMP procedures are in compliance with relevant Company policies and Regulatory requirements.
确保部门的GMP流程符合有关公司政策和法规要求。
6. Facilitate execution of Deviations, investigations, CAPA, etc. related to quality.
处理质量相关的偏差、调查和整改行动等。
7. Establish and manage the efficient operation of the Department documentation control system, including the drawings.
负责建立和管理部门文件管理系统确保其有效的运用,也包括图纸。
8. Develop and coach the team members, build up a professional team to provide maintenance that ensures compliance with GMP for the Operation Service Department. Liaise with other departments to facilitate maintenance in compliance with GMP. Ensure the services are delivered with high quality and efficiency.
发展和辅导团队成员,建立一支专业的业务流程与合规团队,执行维护,确保运营支持部GMP流程的合规性。 与其他部门良好合作, 促进系统维护和GMP流程相关工作的顺利进行。确保提供高质高效的服务。
9. This position is also the financial steward for the department organization that ensures compliance to cost accounting practices and company financial requirements and prudently manages annual spending against OPEX budgets.
本职位也是部门相关的财务管理人,确保符合成本控制程序和公司的财务要求,并且基于OPEX预算管理每年开支。

任职要求:

1. Bachelor in Engineering or pharmaceutical production.
工科或制药类本科。
2. Minimum of 5 years of experience in facility operation and management 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运营管理经验。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
3. Detailed knowledge of the operation of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and HVAC) and general building services (access control, boiler, waste neutralization, chillers, cooling towers, electrical power, emergency generators, compressed gases)’
药厂设施丰富的运行经验(如:纯水、注射水、纯蒸汽、压缩空气、暖通)和建筑维护(如:门禁、锅炉、废水处理、冷冻机、冷却塔、配电、柴油发电机和特气)
4. Technical knowledge regarding the design, operation, preventative maintenance and trouble-shooting of site utilities is required.
有关工厂公用工程的设计,操作,预防性维护和故障排除技术知识是必需的。
5. Experience in equipment commissioning, qualification, and validation programs is required.
设备调试,确认和验证程序方面的经验是必需的。
6. Sound knowledge of Good Manufacturing Practices including NMPA, PIC/S, and US-FDA guidelines with focus on API and/or sterile product manufacture;
熟悉GMP,包括中国药监局,PIC/S和US-FDA在原料药和无菌生产上的法规

招聘人数:1