Brief Job Description 工作描述简述
Equipment maintenance within Packing PET and complete relevant documentation work in compliance with GMP requirement.
按照GMP 的要求,维护包装生产流程执行团队相关生产设备的日常维护活动,并负责完成相关文件工作。
Typical Accountabilities
主要职责
Production equipment maintenance
生产设备维护
• Carry out routine preventive maintenance plan together with engineering group
对设备定期进行预防性维护
• Equipment spare parts ordering and stock management to support production needs
设备备件定购及库存管理,以满足生产需求。
• Identify equipment fault and perform prompt and efficient repairing
及时解决生产中出现的设备故障
• Detect and process potential problem in time by site inspection & other
preventive maintenance 通过现场巡查及预防性维护工作,及时发现和消除设备隐患
• Implement TPM activity 实施TPM活动
Equipment modification ,improvement and Validation activity
设备改造及验证活动
• Involved modify any defectives of equipment to get better performance with
creative and effective solution参与设备缺陷的改造以使其更好的发挥性能
• Suggestion for optimizing operation procedure生产流程优化建议
• Promote parts and components domestic purchasing, refurbishment and
fabricating for cost saving
设备零部件的本地化采购,加工和维修以节约成本
• Drive CI activity and standardize the achievement.
驱动持续改善, 标准化成果。
• Involve in validation & revalidation activity
参与验证或再验证工作
Maintenance record and documentation
维护记录及文件
• Fill and keep preventive maintenance and repairing records correspondingly
and timely
准确及时填写设备维护,维修日志
• Record all maintenance activity timely both in SAP/forms/logbooks and GMP
related document
在SAP/保养表/维修日志及GMP 相关系统中完整及时记录设备维护活动
• Equipment document management
设备资料的日常管理
• Draft technique WIs as required
根据需要起草相关工作指导
GMP code and quality system
GMP 规范和质量体系
• Comply with all the codes and regulations of GMP
遵守所有的GMP 规范和制度
• Understand quality system and follow the requirements and procedures in
maintenances activities
理解质量体系并在维护活动中遵守质量要求和流程
SHE Responsibility
SHE 职责
• Act as a facility SHE team member to implement SHE Policy and Standards
and ensure compliance with local legislation.
• 贯彻执行SHE 政策和标准,并确保与本地法规的一致性
• Assist in all risks identifying and taking preventive actions
确保所在区域所有的风险已得到鉴别澄清,并且已采取相应的预防措施
• Report any SHE incidents happened in responsible area
报告责任区内发生的任何安全事件
• Solve SHE responsibility area problems and communicate with PET SHE
coordinator
解决责任区SHE问题与并PET SHE协调员保持沟通
Other responsibility
其他职责
• Other tasks assigned by line manager
直线经理安排的其他工作
Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力
Education, Qualification, Experience
教育、资质、经验
Capabilities
能力
Academic/Professional qualification 学历/专业资格
• Bachelor degree or above, major in mechanical or electrical automation engineering.
机械或电气自动化专业本科或以上学历
Technical / skills training 技术/技能训练
• Pharma. Packaging knowledge and technical solutions.
医药包装知识和技术解决方案
• Maintenance on motion control, mechanical and pneumatics system and components.
运动控制、机械和气动的系统和组件维护。
Working Experience 工作经验
Essential 必需
• 3 years of working experience
3年及以上工作经验
Language ability 语言能力
• Good English in reading, writing & speaking。
良好的英语读、写、说能力
Computer literacy 电脑知识
• Good MS office skill.
熟练使用微软常用办公软件。
Others 其它
• Good technical Management and communication
internally or externally.
良好的技术管理、内外部交流与辅导能力。
• Familiar with business related regulation /standard.
熟悉行业相关各类法规/标准。