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Quality Control Manager 质量控制部经理牡丹江基纳瑞克斯生物制药有限公司异地招聘1.5-2万/月01-22

学历要求:博士|工作经验:2年|公司性质:外资(欧美)|公司规模:150-500人

1.Responsible for the development, implementation and maintenance of the laboratory quality management system (QMS), and for ensuring that testing and practices are up to current standards. 负责实验室质量管理系统(QMS)的开发、实施和维护,确保检测和实践符合现行的标准。 2.Follow local and international drug regulation. 遵循当地和国际药品法规。 3.Responsible for the review of the quality control documents, including in-house specifications, sampling operation procedures, testing operation procedures, and storage standards of raw materials and excipients, packaging materials, intermediate products, bulk products and finished products. 负责质量控制文件的审核工作,包括原辅料、包装材料、中间产品、待包装产品和成品的内控质量标准、取样操作规程、检验操作规程和贮存标准。 4.Prepare QC (Microbiology and Chemistry laboratories) staff job descriptions. 起草QC(微生物和化学实验室)员工的职位描述。 5.Hire QC staff with the support of Executive Management. 在执行管理层的支持下雇佣QC员工。 6.Undertake QC staff reviews. 承担QC员工的审核工作。 7.Responsible for the training management of labs quality system. 负责实验室质量系统的培训管理工作。 8.To ensure that the required initial and continuing training of her department personnel is carried out and adapted according to need. 确保对本部门实施了所需要的最初培训与持续培训。 9.To ensure the appropriate hygiene requirements of her department. 确保本部门适当的卫生要求。 10.The authorisation of written procedures and other documents, including amendments. 书面程序和其他文件的授权,包括修改。 11.Review and approve SOPs generated for the QC areas. 审核和批准QC部门生成的SOP。 12.To approve specifications,sampling instructions,test methods and other Quality Control procedures. 批准质量标准、取样说明、检验方法以及其他质量控制程序。 13.Manage the development and validation of microbiology and chemistry test methods. Review and approve new and changes to existing test methods. 管理微生物和化学检验方法开发和验证工作,审核和批准新的检验方法和现有检验方法的变更。 14.The inspection,investigation,and taking of samples,in order to monitor factors which may affect product quality. 对样品进行检查、调查和取样,以监测可能影响产品质量的因素。 15.To ensure that all necessary testing is carried out and the associated records evaluated. 确保实施了所有必需的检验和相关记录的审核。 16.Report critical quality control issues to Executive Management immediately. 及时向执行管理层报告关键质量控制问题。 17.Support QA on any investigation requiring further testing. 当QA 在任何调查需要进一步的检测时提供支持。 18.To ensure the monitoring and control of the manufacturing environment. 生产环境的监测与控制。 19.Manage new product development activities for OG and external clients. 为OG和外部客户管理新产品的开发活动。 20.To approve and monitor any contract analysts. 批准和监督任何外包测试。 21.Active participation on review of quality agreement. 积极参与质量协议的审核。 22.To ensure the qualification and maintenance of her department,premises and equipment. 确保本部门场地和设备的确认与维护。 23.To ensure that the appropriate validations are done. 确保实施了适当的验证。 24.The monitoring of compliance with the requirements of Good Manufacturing Practice. 监测与GMP要求的一致性。 25.Involvement in all GMP related matters or issues. 参与所有与GMP相关的事项或问题。 26.Develop and implement product development plans 开发和实施产品开发计划。 27.Work with the Quality Operations and GMP - Accounting Organizations to ensure that the OncoGenerix systems are operating in compliance. 与质量运营部及GMP财务部紧密合作以确保基纳瑞克斯的体系合规运营。 28.Participation in management reviews of process performance,product quality and of the quality management system and advocating continual improvement. 参与工艺流程、产品质量和质量管理体系的管理评审,提倡持续改进。 29.Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management. 确保及时有效的沟通和升级工艺以提高质量管理的水平。 30.Work with QA / RA Department Manager to prepare and implement statistical analysis techniques to accurately trend and document the performance of QC systems. 与QA/RA部门经理一起制定实施统计分析技术以准确的分析和记录QC系统的性能。 31.Responsible to provide data for periodic departmental quality meetings to discuss on going activities, current trends, issues, resolutions, new projects, and plans. 负责向定期召开的部门质量会议提供数据, 就正在进行的工作、目前的趋势、问题、决议、新项目及计划进行讨论。 32.Prepare the Quality Control systems performance report (statistical analysis) for the Weekly Quality Organization Meeting to review trended quality data, staff requirements and quality issues. 为每周的质量部门会议起草质量系统性能报告(统计分析)以审核质量数据的趋势、员工需求和质量事物。 33.Maintain the site Stability program for the whole year such as production sampling schedules, samples pull testing, reporting, individual and family product trajectory ensuring that the continuous stability monitoring program of products has been completed, and the stability monitoring data can be presented during quarterly and Annual Product Review meetings. 维护年度稳定性计划,如产品取样计划、样品检测、报告、单品种和系列产品跟踪等,确保产品持续稳定性监测计划已经完成,并且可以在季度、年度的产品审核会议上提交稳定性监测的数据。 34.Participate in risk management / risk review meetings. 参加风险管理/风险审核会议。 35.Maintains job proficiency and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participate in professional societies. 通过参加教育研究班,查阅专业刊物,建立人脉网络,参加专业协会,精进工作能力和专业知识。 36.Complete any other work task assigned by Director Quality Operations. 完成质量运营总监分配的其他工作任务。

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Quality Control Manager 质量控制部经理牡丹江基纳瑞克斯生物制药有限公司异地招聘1.5-2万/月01-22

学历要求:博士|工作经验:2年|公司性质:外资(欧美)|公司规模:150-500人

1.Responsible for the development, implementation and maintenance of the laboratory quality management system (QMS), and for ensuring that testing and practices are up to current standards. 负责实验室质量管理系统(QMS)的开发、实施和维护,确保检测和实践符合现行的标准。 2.Follow local and international drug regulation. 遵循当地和国际药品法规。 3.Responsible for the review of the quality control documents, including in-house specifications, sampling operation procedures, testing operation procedures, and storage standards of raw materials and excipients, packaging materials, intermediate products, bulk products and finished products. 负责质量控制文件的审核工作,包括原辅料、包装材料、中间产品、待包装产品和成品的内控质量标准、取样操作规程、检验操作规程和贮存标准。 4.Prepare QC (Microbiology and Chemistry laboratories) staff job descriptions. 起草QC(微生物和化学实验室)员工的职位描述。 5.Hire QC staff with the support of Executive Management. 在执行管理层的支持下雇佣QC员工。 6.Undertake QC staff reviews. 承担QC员工的审核工作。 7.Responsible for the training management of labs quality system. 负责实验室质量系统的培训管理工作。 8.To ensure that the required initial and continuing training of her department personnel is carried out and adapted according to need. 确保对本部门实施了所需要的最初培训与持续培训。 9.To ensure the appropriate hygiene requirements of her department. 确保本部门适当的卫生要求。 10.The authorisation of written procedures and other documents, including amendments. 书面程序和其他文件的授权,包括修改。 11.Review and approve SOPs generated for the QC areas. 审核和批准QC部门生成的SOP。 12.To approve specifications,sampling instructions,test methods and other Quality Control procedures. 批准质量标准、取样说明、检验方法以及其他质量控制程序。 13.Manage the development and validation of microbiology and chemistry test methods. Review and approve new and changes to existing test methods. 管理微生物和化学检验方法开发和验证工作,审核和批准新的检验方法和现有检验方法的变更。 14.The inspection,investigation,and taking of samples,in order to monitor factors which may affect product quality. 对样品进行检查、调查和取样,以监测可能影响产品质量的因素。 15.To ensure that all necessary testing is carried out and the associated records evaluated. 确保实施了所有必需的检验和相关记录的审核。 16.Report critical quality control issues to Executive Management immediately. 及时向执行管理层报告关键质量控制问题。 17.Support QA on any investigation requiring further testing. 当QA 在任何调查需要进一步的检测时提供支持。 18.To ensure the monitoring and control of the manufacturing environment. 生产环境的监测与控制。 19.Manage new product development activities for OG and external clients. 为OG和外部客户管理新产品的开发活动。 20.To approve and monitor any contract analysts. 批准和监督任何外包测试。 21.Active participation on review of quality agreement. 积极参与质量协议的审核。 22.To ensure the qualification and maintenance of her department,premises and equipment. 确保本部门场地和设备的确认与维护。 23.To ensure that the appropriate validations are done. 确保实施了适当的验证。 24.The monitoring of compliance with the requirements of Good Manufacturing Practice. 监测与GMP要求的一致性。 25.Involvement in all GMP related matters or issues. 参与所有与GMP相关的事项或问题。 26.Develop and implement product development plans 开发和实施产品开发计划。 27.Work with the Quality Operations and GMP - Accounting Organizations to ensure that the OncoGenerix systems are operating in compliance. 与质量运营部及GMP财务部紧密合作以确保基纳瑞克斯的体系合规运营。 28.Participation in management reviews of process performance,product quality and of the quality management system and advocating continual improvement. 参与工艺流程、产品质量和质量管理体系的管理评审,提倡持续改进。 29.Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management. 确保及时有效的沟通和升级工艺以提高质量管理的水平。 30.Work with QA / RA Department Manager to prepare and implement statistical analysis techniques to accurately trend and document the performance of QC systems. 与QA/RA部门经理一起制定实施统计分析技术以准确的分析和记录QC系统的性能。 31.Responsible to provide data for periodic departmental quality meetings to discuss on going activities, current trends, issues, resolutions, new projects, and plans. 负责向定期召开的部门质量会议提供数据, 就正在进行的工作、目前的趋势、问题、决议、新项目及计划进行讨论。 32.Prepare the Quality Control systems performance report (statistical analysis) for the Weekly Quality Organization Meeting to review trended quality data, staff requirements and quality issues. 为每周的质量部门会议起草质量系统性能报告(统计分析)以审核质量数据的趋势、员工需求和质量事物。 33.Maintain the site Stability program for the whole year such as production sampling schedules, samples pull testing, reporting, individual and family product trajectory ensuring that the continuous stability monitoring program of products has been completed, and the stability monitoring data can be presented during quarterly and Annual Product Review meetings. 维护年度稳定性计划,如产品取样计划、样品检测、报告、单品种和系列产品跟踪等,确保产品持续稳定性监测计划已经完成,并且可以在季度、年度的产品审核会议上提交稳定性监测的数据。 34.Participate in risk management / risk review meetings. 参加风险管理/风险审核会议。 35.Maintains job proficiency and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participate in professional societies. 通过参加教育研究班,查阅专业刊物,建立人脉网络,参加专业协会,精进工作能力和专业知识。 36.Complete any other work task assigned by Director Quality Operations. 完成质量运营总监分配的其他工作任务。

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Quality Control Manager 质量控制部经理牡丹江基纳瑞克斯生物制药有限公司异地招聘1.5-2万/月01-22

学历要求:博士|工作经验:2年|公司性质:外资(欧美)|公司规模:150-500人

1.Responsible for the development, implementation and maintenance of the laboratory quality management system (QMS), and for ensuring that testing and practices are up to current standards. 负责实验室质量管理系统(QMS)的开发、实施和维护,确保检测和实践符合现行的标准。 2.Follow local and international drug regulation. 遵循当地和国际药品法规。 3.Responsible for the review of the quality control documents, including in-house specifications, sampling operation procedures, testing operation procedures, and storage standards of raw materials and excipients, packaging materials, intermediate products, bulk products and finished products. 负责质量控制文件的审核工作,包括原辅料、包装材料、中间产品、待包装产品和成品的内控质量标准、取样操作规程、检验操作规程和贮存标准。 4.Prepare QC (Microbiology and Chemistry laboratories) staff job descriptions. 起草QC(微生物和化学实验室)员工的职位描述。 5.Hire QC staff with the support of Executive Management. 在执行管理层的支持下雇佣QC员工。 6.Undertake QC staff reviews. 承担QC员工的审核工作。 7.Responsible for the training management of labs quality system. 负责实验室质量系统的培训管理工作。 8.To ensure that the required initial and continuing training of her department personnel is carried out and adapted according to need. 确保对本部门实施了所需要的最初培训与持续培训。 9.To ensure the appropriate hygiene requirements of her department. 确保本部门适当的卫生要求。 10.The authorisation of written procedures and other documents, including amendments. 书面程序和其他文件的授权,包括修改。 11.Review and approve SOPs generated for the QC areas. 审核和批准QC部门生成的SOP。 12.To approve specifications,sampling instructions,test methods and other Quality Control procedures. 批准质量标准、取样说明、检验方法以及其他质量控制程序。 13.Manage the development and validation of microbiology and chemistry test methods. Review and approve new and changes to existing test methods. 管理微生物和化学检验方法开发和验证工作,审核和批准新的检验方法和现有检验方法的变更。 14.The inspection,investigation,and taking of samples,in order to monitor factors which may affect product quality. 对样品进行检查、调查和取样,以监测可能影响产品质量的因素。 15.To ensure that all necessary testing is carried out and the associated records evaluated. 确保实施了所有必需的检验和相关记录的审核。 16.Report critical quality control issues to Executive Management immediately. 及时向执行管理层报告关键质量控制问题。 17.Support QA on any investigation requiring further testing. 当QA 在任何调查需要进一步的检测时提供支持。 18.To ensure the monitoring and control of the manufacturing environment. 生产环境的监测与控制。 19.Manage new product development activities for OG and external clients. 为OG和外部客户管理新产品的开发活动。 20.To approve and monitor any contract analysts. 批准和监督任何外包测试。 21.Active participation on review of quality agreement. 积极参与质量协议的审核。 22.To ensure the qualification and maintenance of her department,premises and equipment. 确保本部门场地和设备的确认与维护。 23.To ensure that the appropriate validations are done. 确保实施了适当的验证。 24.The monitoring of compliance with the requirements of Good Manufacturing Practice. 监测与GMP要求的一致性。 25.Involvement in all GMP related matters or issues. 参与所有与GMP相关的事项或问题。 26.Develop and implement product development plans 开发和实施产品开发计划。 27.Work with the Quality Operations and GMP - Accounting Organizations to ensure that the OncoGenerix systems are operating in compliance. 与质量运营部及GMP财务部紧密合作以确保基纳瑞克斯的体系合规运营。 28.Participation in management reviews of process performance,product quality and of the quality management system and advocating continual improvement. 参与工艺流程、产品质量和质量管理体系的管理评审,提倡持续改进。 29.Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management. 确保及时有效的沟通和升级工艺以提高质量管理的水平。 30.Work with QA / RA Department Manager to prepare and implement statistical analysis techniques to accurately trend and document the performance of QC systems. 与QA/RA部门经理一起制定实施统计分析技术以准确的分析和记录QC系统的性能。 31.Responsible to provide data for periodic departmental quality meetings to discuss on going activities, current trends, issues, resolutions, new projects, and plans. 负责向定期召开的部门质量会议提供数据, 就正在进行的工作、目前的趋势、问题、决议、新项目及计划进行讨论。 32.Prepare the Quality Control systems performance report (statistical analysis) for the Weekly Quality Organization Meeting to review trended quality data, staff requirements and quality issues. 为每周的质量部门会议起草质量系统性能报告(统计分析)以审核质量数据的趋势、员工需求和质量事物。 33.Maintain the site Stability program for the whole year such as production sampling schedules, samples pull testing, reporting, individual and family product trajectory ensuring that the continuous stability monitoring program of products has been completed, and the stability monitoring data can be presented during quarterly and Annual Product Review meetings. 维护年度稳定性计划,如产品取样计划、样品检测、报告、单品种和系列产品跟踪等,确保产品持续稳定性监测计划已经完成,并且可以在季度、年度的产品审核会议上提交稳定性监测的数据。 34.Participate in risk management / risk review meetings. 参加风险管理/风险审核会议。 35.Maintains job proficiency and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participate in professional societies. 通过参加教育研究班,查阅专业刊物,建立人脉网络,参加专业协会,精进工作能力和专业知识。 36.Complete any other work task assigned by Director Quality Operations. 完成质量运营总监分配的其他工作任务。

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