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    Quality engineer II - Jiaxing, 中国 - Abbott

    Abbott
    Abbott Jiaxing, 中国

    发现在: Talent CN S2 - 4天前

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    描述

    主要职责 Core Job Responsibilities

  • 熟悉变更控制,验证和纠正措施知识并精通运用
  • Master Consumable Control, Validation and CAPA (Corrective Action and

    • Preventive Action)

  • 具备运用M-files, TrackWise等工具以维护质量系统
  • Knowledge to use Quality Operations tools including M-files, and TrackWise to maintain quality system
  • 推广质量工具(FMEA,SPC,DOE等),以提高生产工艺及设备和产品质量
  • Promote the Quality Tools (FMEA, SPC, DOE and etc.), to improve process, equipment and product quality
  • 了解生产工艺及流程
  • Knowledge on the manufacturing process
  • 具备工程技能知识包括:
  • Equipped with basic engineering knowledge including:
  • 金属材料(如不锈钢、碳钢、铸铁)的应用知识

    • Metalic material application (including stainless steel, iron etc.)

  • 润滑油基础知识

    • Basic knowledge of lubricant

  • 橡胶密封件的应用

    • Application of rubbery gasket

  • 管道和设备安装和验收

    • Piping and equipment installation and commissioning acceptance

  • 机械传动结构和原理(如齿轮、链轮、皮带传动等)

    • Mechanical drive structure and theory (including gear wheel, chain wheel and strap drive etc.)

  • 具备生产自动化控制知识
  • Knowledge of manufacturing automation control
  • 具备工厂物料及成品管理知识
  • Knowledge of plant material and finished good management
  • 在日常工作中能独立发现问题并解决及改善
  • Able to discover problem in daily work and resolve the issue accordingly
  • 掌握RCA(6M原因分析)和5WHY工具,能对事件原因进行分析
  • Master of RCA (Root Cause Analysis – 6M) and 5 WHY tools, and use the tools to analyze and identify root cause
  • 作为质量部代表,参与事件调查和原因分析
  • As representative of quality department involve in event investigation and root cause analysis
  • 对出现的质量隐患点进行分析并能对设备或生产工艺进行改进
  • Able to identify critical point, analyze and improvement opportunity for manufacturing equipment and process
  • 具备能力与亚太区及总部专业领域专家进行工厂事件沟通及评估以解决该事件的问题
  • Communicate with Abbott Division and Regional SME on ANJX event for assessment in order to resolve the event
  • 处理变更控制,验证和纠正措施的操作文件
  • Handle associated documentation for Consumable Control, Validation, Customer Complaint and CAPA
  • 管理日常文件并确保文件GDP(良好文件规范)符合性及对其进行归档
  • Handle routine documentation, ensure compliance with GDP (Good Documentation Practice) and archive the document in repository
  • 具备书写质量调查报告能力
  • Be able to write quality investigation report.
  • 具备审核报告能力,并提供意见
  • Ability to review report and provide comment
  • 起草及改进变更控制,验证和纠正措施的操作流程
  • Prepare and revise SOP (Standard Operating Procedure) related to Consumable Control, Validation and CAPA (Corrective Action and Preventive Action)
  • 对工厂相关人员进行变更控制,验证和纠正措施的培训
  • Ability to perform training to ANJX colleagues related to Consumable Control, Validation and CAPA (Corrective Action and Preventive Action)
  • 能与各部门进行有效沟通,制定解决方案。跟进方案的进度及结果,对结果进行分析以做出结论
  • Able to have an effective communication with different function department to develop a protocol for an event resolution. Follow up the protocol and track on the progress. Analyze result with conclusion
  • 主管指派的其它任务
  • Other task assigned by superior

    • 最低学历要求 Minimum Education

  • 要求本科或以上学位(药品及食品相关专业)
  • Bachelor degree or above in Food and Pharmaceutical related discipline

    • 最低经验 / 培训要求 Minimum Experience / Training Required

  • 具备两年在食品药品生产领域的经验
  • 2 years working experience in food/pharmaceutical industry
  • 要求在食品药品生产领域具备良好的GMP(良好生产规范)及GDP(良好文件规范)实用知识
  • Good practical knowledge of GMP and GDP in food/pharmaceutical manufacturing
  • 好的文档管理实践知识
  • Good knowledge and practice in documentation management
  • 了解HACCP和ISO系统知识的将优先考虑
  • Knowledge of HACCP and ISO systems would be preferred
  • 具有相关工作经历并对制造过程有所理解
  • working exposure and understanding of manufacturing process
  • 具备相关的工作经验及/或学历
  • Relevant experience or equivalent combination of education and work experience
  • 具备团队协作能力和良好的沟通技巧
  • Team player with collaboration capability and good communication skills
  • 掌握婴幼儿配方乳粉产品涉及的质量法规,了解应承担的责任和义务
  • Familiar with infant formula dairy product regulation, and knowledge of the role and responsibility

    • definition by regulation would be preferred

  • 掌握质量运营工具包括M-files, GQMS and Trackwise
  • Knowledge to use Quality Operations tools including M-files, GQMS and Trackwise
  • 具备良好英语和普通话的读,听,口语和写作能力
  • Able to read, write, listen and speak in English and Mandarin
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