At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Shanghai China
Job Description:
章节1岗位概述
- Assist in production process risk management and process control.
- 协助生产过程风险管理和过程控制
- Assist in administrator of the equipment system.
- 协助实验室设备系统管理员
- Assist in quality culture activities.
- 协助质量文化活动
- Assist in handling BOP in quality department.
- 协助处理质量部BOP
- As LMS administrator.
- 作为LMS管理员
章节2职责和责任
- As production process risk management and process control coordinator assist in maintaining risk management documents on-site IPQA material disposition of short expiry date test data review and analysis provide product COC and other related tasks.
- 作为生产过程风险管理和过程控制协调员协助维护风险管理文件现场IPQA短有效期物料处置测试数据审阅分析出具产品符合性证明等相关工作
- Assist lab equipment system administrator address lab system user access review lab system audit trail review and data backup.
- 协助实验室设备系统管理员执行实验室设备用户权限管理审计追踪审阅和数据备份
- As quality culture coordinator assist in routine Great Catch cases collection disposition and feedback and promote site quality culture and hold quality culture activities.
- 作为质量文化协调员协助日常Great Catch收集处置和反馈以及推动工厂质量文化和举办质量文化活动
- As quality building ownership program coordinator assist the Facility Department in handling BOP
- 作为质量部BOP协调员协助设施部处理BOP
- As LMS administrator create/maintain/assign training items provide training data/reports based on business needs and support the execution of training activities at the Minhang site.
- 作为LMS管理员创建/维护/分配培训课程根据业务需求提供培训数据/报告支持闵行工厂的培训执行工作
- Responsible for communicating business related issues or opportunities to next management level.
- 负责将业务相关问题或机会传达给下一级管理层
- Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
- 负责遵循公司与健康安全和环境相关的所有适用的实践
- For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable
- 对于那些监督或管理员工的人员如适用负责确保下属遵循与健康安全和环境实践相关的所有公司指南以及所有需要的资源都是可用的且状况良好
- Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
- 负责确保个人和公司遵守联邦州地方和公司的所有法规政策和程序
- Performs other duties assigned as needed
- 执行其他必要的职责
章节 3经验和教育
- University/Bachelors Degree or Equivalent.
- 大学本科学历或同等学历
- 1-2 years of experience in Quality function in Medical Devices or Pharmaceutical industry.
- 1-2年在医疗器械或医药行业质量部门的经验
- Better to have knowledge of medical device regulatory requirement such as ISO13485 and China GMP is necessary and some professional skills such as FMEA Minitab Power BI.
- 最好具有医疗器械法规要求的具体知识比如ISO13485 和China GMP以及专业技能比如FMEA Minitab Power BI
Required Skills:
Preferred Skills:
Analytical Reasoning Business Behavior Compliance Management Detail-Oriented Execution Focus Goal Attainment Human-Centered Design Internal Controls Process Oriented Quality Assurance (QA) Quality Control (QC) Quality Management Systems (QMS) Quality Processes Quality Standards
Required Experience:
IC
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Shanghai China
Job Description:
章节1岗位概述
- Assist in production process risk management and process control.
- 协助生产过程风险管理和过程控制
- Assist in administrator of the equipment system.
- 协助实验室设备系统管理员
- Assist in quality culture activities.
- 协助质量文化活动
- Assist in handling BOP in quality department.
- 协助处理质量部BOP
- As LMS administrator.
- 作为LMS管理员
章节2职责和责任
- As production process risk management and process control coordinator assist in maintaining risk management documents on-site IPQA material disposition of short expiry date test data review and analysis provide product COC and other related tasks.
- 作为生产过程风险管理和过程控制协调员协助维护风险管理文件现场IPQA短有效期物料处置测试数据审阅分析出具产品符合性证明等相关工作
- Assist lab equipment system administrator address lab system user access review lab system audit trail review and data backup.
- 协助实验室设备系统管理员执行实验室设备用户权限管理审计追踪审阅和数据备份
- As quality culture coordinator assist in routine Great Catch cases collection disposition and feedback and promote site quality culture and hold quality culture activities.
- 作为质量文化协调员协助日常Great Catch收集处置和反馈以及推动工厂质量文化和举办质量文化活动
- As quality building ownership program coordinator assist the Facility Department in handling BOP
- 作为质量部BOP协调员协助设施部处理BOP
- As LMS administrator create/maintain/assign training items provide training data/reports based on business needs and support the execution of training activities at the Minhang site.
- 作为LMS管理员创建/维护/分配培训课程根据业务需求提供培训数据/报告支持闵行工厂的培训执行工作
- Responsible for communicating business related issues or opportunities to next management level.
- 负责将业务相关问题或机会传达给下一级管理层
- Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
- 负责遵循公司与健康安全和环境相关的所有适用的实践
- For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable
- 对于那些监督或管理员工的人员如适用负责确保下属遵循与健康安全和环境实践相关的所有公司指南以及所有需要的资源都是可用的且状况良好
- Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
- 负责确保个人和公司遵守联邦州地方和公司的所有法规政策和程序
- Performs other duties assigned as needed
- 执行其他必要的职责
章节 3经验和教育
- University/Bachelors Degree or Equivalent.
- 大学本科学历或同等学历
- 1-2 years of experience in Quality function in Medical Devices or Pharmaceutical industry.
- 1-2年在医疗器械或医药行业质量部门的经验
- Better to have knowledge of medical device regulatory requirement such as ISO13485 and China GMP is necessary and some professional skills such as FMEA Minitab Power BI.
- 最好具有医疗器械法规要求的具体知识比如ISO13485 和China GMP以及专业技能比如FMEA Minitab Power BI
Required Skills:
Preferred Skills:
Analytical Reasoning Business Behavior Compliance Management Detail-Oriented Execution Focus Goal Attainment Human-Centered Design Internal Controls Process Oriented Quality Assurance (QA) Quality Control (QC) Quality Management Systems (QMS) Quality Processes Quality Standards
Required Experience:
IC
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