岗位职责:

一、设备管理 Equipment acceptance management

1. 负责对设备进行全生命周期管理，设备的进场验收、安装和调试，设备标签和标识牌发放、设备技术档案的归档等

Be responsible for the whole life cycle management of equipment, the mobilization acceptance, installation and commissioning of equipment, the issuance of equipment labels and identification plates, and the filing of equipment technical archives, etc.

2. 负责设备的FAT、SAT和IOQ的验收工作

Responsible for the acceptance of FAT, SAT and IOQ of the equipment

3. 负责公司工艺设备的维护保养工作，确保生产的正常运行；

Responsible for the maintenance of the company's process equipment to ensure the normal operation of production.

4. 负责工艺设备故障及时组织处理，确保设备始终处于良好的运行状态；

Responsible for the timely organization and treatment of process equipment failures to ensure that the equipment is always in good operating condition.

5. 负责工艺设备偏差、变更、CAPA的发起、审核、跟进

Responsible for the initiation, review and follow-up of process equipment deviation, change and CAPA

二、文件管理Document Management

1. 负责本部门工艺设备管理文件、维保作业指导书的起草，并按照SOP要求严格执行

Responsible for the drafting of the department's process equipment management documents and maintenance work instructions, and strictly implement them according to SOP requirements

2. 负责SAP PM模块SOP和作业指导书的起草，并按照SOP要求严格执行

Responsible for the drafting of SOP and work instructions for SAP PM modules, and strictly implement them according to SOP requirements

三、培训管理Training Management

1. 按时完成TMS系统下达的各项培训

Complete all training issued by TMS system on time

2. 按时完成本部门起草/升版的培训

Complete the training of the department's draft/upgrade version on time

四、 组织管理Organizational Management

1. 工作计划：按照分配的工作任务制定工作计划，并实施

Work plan: Develop a work plan in accordance with the assigned work tasks and implement it

2. 部门会议：参加部门会议，积极反馈相关的工作内容

Departmental meetings: Attend departmental meetings and provide active feedback on relevant work content

3. 绩效考核：根据公司管理要求制订绩效计划

Performance appraisal: Develop performance plans according to company management requirements

任职要求:

本科以上要求

Bachelor degree or above required

有药品生产企业五年以上工作经验，熟悉大部分药厂设备

More than 5 years working experience in pharmaceutical manufacturing company, familiar with most pharmaceutical equipment

熟练掌握GMP指南要求以及各国家法规对工艺设备的要求

Good command of GMP guidelines and national regulations on process equipment requirements

熟练掌握设备维修维护技术；具有良好的团队协作能力以及沟通协调能力

Proficient in equipment maintenance technology; Good teamwork and communication skills

具有良好的英文读写能力优先；

Good English reading and writing skills are preferred;