质量经理（Q&C）-上海-00000KJV
说明
1. Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
v Quality management in distribution center of Shanghai
上海物流中心的质量管理
Ø As quality manager, responsible for leading or key team member for quality project in SH-NDC, such as audit of internal, external and J&J ERC, SH-DC extension and Cold Chain in storage and transportation process.
作为经理负责或者关键参与者上海物流中心的质量项目。如：内部和外部质量审计，强生总部质量审计，上海物流中心的改扩建项目和冷链储存运输项目。
Ø Be responsible for lead and manage routine quality management in operation process, such as NC, CAPA Case and process improvement in SH-DC
负责日常上海物流中心操作过程的质量管理。如：不合格事件，纠正预防措施事件和流程优化等。
Ø Be responsibility for lead and manage QA Engineer/Technician/3rd PL Inspector in SH-DC
负责和管理上海物流中心QA工程师/技术员/第三方现场检查员
v Chinese label quality control for incoming goods
进口产品中文标签的质量管理：
Ø Be responsible for lead and review that QA Engineer/Technician complete the change control process for Chinese label according to requirements, and establish the process/protocol to meet company’s requirements if necessary;
能够按照要求，指导QA工程师/技术员完成进口产品中文标签格式的变更流程，在必要时起草相关草案，并确保符合公司的要求；
Ø Be responsible for review and approve the first article inspection for Chinese label and release the product in ERP system in time, and monitor the routine Chinese label release if need;
如果需要，在ERP系统中，负责评估和批准初次产生和变更的中文标签的核对和放行工作，并对ERP系统中文标签放行进行日常监控；
Ø Be responsible for review the change control process for Chinese label from Label-View system as BCP, and correct the defect Chinese label on site. At the same time to update the Label-View Chinese label standard. If necessary, correct the impact inventory and impact goods which in distributors.
负责评估BCP方案的进口产品中文标签Label-View的变更申请和批准流程；必要时，对怀疑错误的中文标签进行检查，并按照要求完成该中文标签的变更申请和批准流程，对库存产品或经销商处的库存产品实施产品中文标签的现场纠正；
Ø Be responsible for review the Chinese label standards weekly which initiated by QA Engineer/ Technician to be sure all the process are under control;
负责每周核对由QA工程师/技术员审核的产品中文标签标准，并确保其流程得到控制；
v Chinese IFU quality control for incoming goods
进口产品中文说明书的质量管理：
Ø Be responsible for finish the change control process for Chinese IFU according to requirements, and establish the process/protocol to meet company’s requirements if necessary;
负责能够按照要求及时完成进口产品中文说明书的新建及变更流程，在必要时起草相关草案，并确保符合公司的要求；
Ø Be responsible for monitor the Chinese IFUs insert process locally, and work with related department for Chinese IFU management.
负责监控本地添加中文说明书的质量控制，并且协调相关部门对中文说明书的管理。
v Incoming goods inspection
进口产品的货物检查：
Ø Be responsible for review and approve the incoming goods inspection report which is defected by QA Engineer/ Technician;
负责对质量工程师/技术员完成的日常进口产品货物检查报告进行复核和批准；
Ø Be responsible for review the complaint case which report in LOG and be sure the information is correct; Be sure all the complaint report to CHU in 24 hours and record the all files for tracking if need;
负责对在日常进口产品货物检查过程中所产生的投诉事件进行核对和评估，确保其准确和合适；确保投诉在24小时内上报投诉中心，并及时做好记录以便跟踪追溯；
Ø Be responsible for review and approve the incoming goods receiving reports which done by QA Engineer/Technician and be sure all the information in goods are match with the licenses, reminder quality engineer for filing all the reports everyday;
负责评估和批准对工程师/质量技术员完成的日常进口产品货物的入库检查报告，确保进口产品注册信息的符合性；提醒质量工程师每日及时完成报告的复核和归档。
v Return goods inspection
退货产品的货物检查：
Ø Be responsible for review and approve the return goods inspection reports which done by QA Engineer/Technician; and provide quality training and support if necessary;
负责对质量工程师/技术员完成的日常退货产品检查报告进行复核；并在需要的时候提供质量技术的支持和培训；
Ø To communicate with related departments when handle the return case, and provide the resolve protocols for franchise and distributors if necessary;
在必要的时候处理因产品退货而产生的沟通问题，为产品事业部、经销商提供解决方案；
v Routine monitor in warehouse
仓库的日常监控：
Ø Be responsible for review and evaluate the temperature records weekly, be sure all the products are under storage condition;
负责每周对仓库的温度记录作核对和评估，确保其符合产品储存的要求；
Ø Be responsible for review the insect pest control records monthly, if have issue, inform Manager in time;
负责每月审核仓库的虫害控制记录，如有非正常情况，立即报告经理；
Ø Be responsible for monitor the incoming goods storage and deliver environment, if have issue, inform Manager in time;
负责监控进口产品的储存和运输环境，提供符合性依据；如有非正常情况，立即报告经理；
v Document management, NC case and CAPA handling
文件管理、不合格事件、纠正预防措施：
Ø Establish the SOP and GOP for incoming goods quality;
起草、准备与进口产品质量符合性相关的SOP和GOP；
Ø Handling the NC case until close according to current GOP/SOP;
按照现行的GOP/SOP规定，及时处理并跟进不合格事件直至其结束；
Ø Handling the CAPA until close according to current GOP/SOP;
按照现行的GOP/SOP规定，及时处理并跟进产品和过程的纠正预防措施直至其结束；
v Arrange and Fulfill project assigned as a project owner.
作为项目所有者完成项目的安排及执行。
v Fulfill other tasks assigned.
履行指派的任务
v Comply with EHS & ISO14001.
按照EHS和ISO 14001要求执行
资历
1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）
v Bachelor degree or above on chemical, pharmaceutical or related subjects.
大学或以上毕业，化学、制药或相关专业
v Above 10 years experience in quality compliance management or related areas in medical device or pharmaceutical industries.
10年以上医疗器材或医药相关质量管理工作经验
v Good communication, cooperation and organization skills.As
优良的沟通、协调和组织能力
v English fluent in reading, writing, oral, listening.
熟练的英语读、写和听能力
v Familiar with routine operations of computer and software.
熟练的基本计算机和软件操作能力
2. Skill Sets and/or Training and/or Certification for the Special Position
特殊岗位的技能和/或培训和/或证书要求
Pharm. License
执业药师
Quality Engineer
质量工程师
主要地点: 亚太地区-中国-上海-上海
组织: - 强生（上海）医疗器材有限公司
工作: Quality Assurance
说明
1. Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
v Quality management in distribution center of Shanghai
上海物流中心的质量管理
Ø As quality manager, responsible for leading or key team member for quality project in SH-NDC, such as audit of internal, external and J&J ERC, SH-DC extension and Cold Chain in storage and transportation process.
作为经理负责或者关键参与者上海物流中心的质量项目。如：内部和外部质量审计，强生总部质量审计，上海物流中心的改扩建项目和冷链储存运输项目。
Ø Be responsible for lead and manage routine quality management in operation process, such as NC, CAPA Case and process improvement in SH-DC
负责日常上海物流中心操作过程的质量管理。如：不合格事件，纠正预防措施事件和流程优化等。
Ø Be responsibility for lead and manage QA Engineer/Technician/3rd PL Inspector in SH-DC
负责和管理上海物流中心QA工程师/技术员/第三方现场检查员
v Chinese label quality control for incoming goods
进口产品中文标签的质量管理：
Ø Be responsible for lead and review that QA Engineer/Technician complete the change control process for Chinese label according to requirements, and establish the process/protocol to meet company’s requirements if necessary;
能够按照要求，指导QA工程师/技术员完成进口产品中文标签格式的变更流程，在必要时起草相关草案，并确保符合公司的要求；
Ø Be responsible for review and approve the first article inspection for Chinese label and release the product in ERP system in time, and monitor the routine Chinese label release if need;
如果需要，在ERP系统中，负责评估和批准初次产生和变更的中文标签的核对和放行工作，并对ERP系统中文标签放行进行日常监控；
Ø Be responsible for review the change control process for Chinese label from Label-View system as BCP, and correct the defect Chinese label on site. At the same time to update the Label-View Chinese label standard. If necessary, correct the impact inventory and impact goods which in distributors.
负责评估BCP方案的进口产品中文标签Label-View的变更申请和批准流程；必要时，对怀疑错误的中文标签进行检查，并按照要求完成该中文标签的变更申请和批准流程，对库存产品或经销商处的库存产品实施产品中文标签的现场纠正；
Ø Be responsible for review the Chinese label standards weekly which initiated by QA Engineer/ Technician to be sure all the process are under control;
负责每周核对由QA工程师/技术员审核的产品中文标签标准，并确保其流程得到控制；
v Chinese IFU quality control for incoming goods
进口产品中文说明书的质量管理：
Ø Be responsible for finish the change control process for Chinese IFU according to requirements, and establish the process/protocol to meet company’s requirements if necessary;
负责能够按照要求及时完成进口产品中文说明书的新建及变更流程，在必要时起草相关草案，并确保符合公司的要求；
Ø Be responsible for monitor the Chinese IFUs insert process locally, and work with related department for Chinese IFU management.
负责监控本地添加中文说明书的质量控制，并且协调相关部门对中文说明书的管理。
v Incoming goods inspection
进口产品的货物检查：
Ø Be responsible for review and approve the incoming goods inspection report which is defected by QA Engineer/ Technician;
负责对质量工程师/技术员完成的日常进口产品货物检查报告进行复核和批准；
Ø Be responsible for review the complaint case which report in LOG and be sure the information is correct; Be sure all the complaint report to CHU in 24 hours and record the all files for tracking if need;
负责对在日常进口产品货物检查过程中所产生的投诉事件进行核对和评估，确保其准确和合适；确保投诉在24小时内上报投诉中心，并及时做好记录以便跟踪追溯；
Ø Be responsible for review and approve the incoming goods receiving reports which done by QA Engineer/Technician and be sure all the information in goods are match with the licenses, reminder quality engineer for filing all the reports everyday;
负责评估和批准对工程师/质量技术员完成的日常进口产品货物的入库检查报告，确保进口产品注册信息的符合性；提醒质量工程师每日及时完成报告的复核和归档。
v Return goods inspection
退货产品的货物检查：
Ø Be responsible for review and approve the return goods inspection reports which done by QA Engineer/Technician; and provide quality training and support if necessary;
负责对质量工程师/技术员完成的日常退货产品检查报告进行复核；并在需要的时候提供质量技术的支持和培训；
Ø To communicate with related departments when handle the return case, and provide the resolve protocols for franchise and distributors if necessary;
在必要的时候处理因产品退货而产生的沟通问题，为产品事业部、经销商提供解决方案；
v Routine monitor in warehouse
仓库的日常监控：
Ø Be responsible for review and evaluate the temperature records weekly, be sure all the products are under storage condition;
负责每周对仓库的温度记录作核对和评估，确保其符合产品储存的要求；
Ø Be responsible for review the insect pest control records monthly, if have issue, inform Manager in time;
负责每月审核仓库的虫害控制记录，如有非正常情况，立即报告经理；
Ø Be responsible for monitor the incoming goods storage and deliver environment, if have issue, inform Manager in time;
负责监控进口产品的储存和运输环境，提供符合性依据；如有非正常情况，立即报告经理；
v Document management, NC case and CAPA handling
文件管理、不合格事件、纠正预防措施：
Ø Establish the SOP and GOP for incoming goods quality;
起草、准备与进口产品质量符合性相关的SOP和GOP；
Ø Handling the NC case until close according to current GOP/SOP;
按照现行的GOP/SOP规定，及时处理并跟进不合格事件直至其结束；
Ø Handling the CAPA until close according to current GOP/SOP;
按照现行的GOP/SOP规定，及时处理并跟进产品和过程的纠正预防措施直至其结束；
v Arrange and Fulfill project assigned as a project owner.
作为项目所有者完成项目的安排及执行。
v Fulfill other tasks assigned.
履行指派的任务
v Comply with EHS & ISO14001.
按照EHS和ISO 14001要求执行
资历
1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）
v Bachelor degree or above on chemical, pharmaceutical or related subjects.
大学或以上毕业，化学、制药或相关专业
v Above 10 years experience in quality compliance management or related areas in medical device or pharmaceutical industries.
10年以上医疗器材或医药相关质量管理工作经验
v Good communication, cooperation and organization skills.As
优良的沟通、协调和组织能力
v English fluent in reading, writing, oral, listening.
熟练的英语读、写和听能力
v Familiar with routine operations of computer and software.
熟练的基本计算机和软件操作能力
2. Skill Sets and/or Training and/or Certification for the Special Position
特殊岗位的技能和/或培训和/或证书要求
Pharm. License
执业药师
Quality Engineer
质量工程师
主要地点: 亚太地区-中国-上海-上海
组织: - 强生（上海）医疗器材有限公司
工作: Quality Assurance