验证工程师 牡丹江

月薪： 0.6-1万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招2人
  • 01-02 发布
  • 五险一金
  • 免费班车
  • 绩效奖金
  • 年终奖金
  • 定期体检
  • 免费公寓

职位描述

At the direction of area supervisor:在区域主管的领导下：1.Prepare, review, implement and maintain Validation SOPs.起草、审核、实施和维护验证SOP。2.As required participate in Weekly Engineering Organization Meetings.根据需要参加每周质量部会议。3.In conjunction with system owners and in accordance with the Validation Master Plan prepare GAMP documentation for new equipment and systems.协同运营部按照验证主计划为新设备和系统制定GAMP文件。4.In conjunction with system owners review supplier submitted documentation for new equipment and systems.协同运营部审核供应商提交的新设备和系统的文件。5.In conjunction with system owners and in accordance with the Validation Master Plan prepare qualification and validation protocols for new equipment and systems.协同运营部按照验证主计划起草新设备和系统的确认和验证方案。6.In conjunction with system owners execute qualification and validation protocols for new equipment and systems.协同运营部执行新设备和系统的确认和验证方案。7.In conjunction with system owners document / resolve deviations identified when executing qualification and validation protocols for new equipment and systems.协同运营部记录/解决新设备和系统确认和验证方案执行中发现的偏差。8.Prepare qualification summary reports for executed qualification and validation protocols for new equipment and systems.为已执行确认和验证的新设备和系统起草确认总结报告。9.In conjunction with system owners and in accordance with the Validation Master Plan prepare Continued Process Verification (CPV) Validation Protocols for validated equipment and systems.协同运营部按照验证主计划为已验证的设备和系统起草再验证方案。10.In conjunction with system owners execute CPV protocols for validated equipment and systems.协同运营部执行设备和系统的再验证方案。11.In conjunction with system owners document / resolve deviations identified when executing CPV protocols for validated equipment and systems.协同运营部记录/解决在执行设备和系统的再验证方案过程中出现的偏差。12.Prepare qualification summary reports for executed CPV protocols for validated equipment and systems.起草已执行再验证方案的设备和系统的确认总结报告。13.Ensure that all test equipment is in the appropriate calibrated state before use.确保所有的检验设备在使用前已经过适当的校准。14.Notify the Validation Supervisor immediately if a requirement of any qualification, validation or revalidation protocol fails to be met.如果在确认、验证或再验证方案的执行过程中出现不符合情况，及时通知QA经理。15.In conjunction with system owners maintain equipment and systems documents (including GAMP documents).协同运营部维护设备和系统文件（包括GAMP文件）。16.Maintain the equipment and systems qualification, validation and revalidation documents.保存设备和系统的确认、验证和再验证文件。17.Maintain associated equipment and systems qualification and validation document logs.维护设备和系统的确认和验证文件台账 职能类别： 生物工程/生物制药

联系方式

海林市海林经济开发区东旭路7号

公司信息

公司总部位于美国加利福尼亚州圣地亚哥，生产工厂位于中国东北部风景优美的黑龙江省。基纳瑞克斯提供包括技术转移、工艺开发、放大实验、设备/工艺验证，配液、灌装、冻干、检验、完整性检测、贴标签及装盒等的整套服务，符合美国食药监局、欧洲药品管理局、中国食药监局及日本法规机构的要求。With our corporate headquarters located in San Diego, California, USA and our manufacturing facility located in the scenic Heilongjiang Province in the north eastern part of China OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulatory

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