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RPO/HR · 诺和诺德中国

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职位介绍: Key areas of responsibility 主要工作职责: The QC CDP professional is responsible for QC technical tasks on a daily basis. Act as QC expert and audit technical responsible in department, follow up all quality actions, identify and drive improvement，etc. To ensure a high level of compliance with quality and EHS 质量控制专员负责质量控制的技术性工作。在日常工作中作为部门中的质量控制专家和审计的技术责任人，跟踪所有质量活动，识别和推动改进项目等。应确保所有的活动符合质量和EHS相关的要求 Main Job Tasks 主要工作任务: •Drive continually improvement to optimize process within QC CDP team by using cLEAN® way. 在QC CDP部门内，运用cLEAN®的方法和工具推动持续改进、优化工作流程。 •Act as QC inspection expert and provide technical support to QC CDP operator and technician. Review the specification of QC inspection method and give input to owner, address problems in a structured and standardized way and coach others in doing the same. 作为QC检验的专家向QC CDP操作员和技术员提供技术支持。复核QC检验标准并向相应的负责人提供建议；发现并纠正问题；指导检验人员工作标准化。 •Trouble shooting in relation to quality issues. Handle NC, CR, QAP cases. Identify risk and problems related to QC CDP, investigate root-cause, recommend solution. 解决质量问题；处理NC，CR和QAP；发现QC CDP 相关的风险和潜在问题、调查原因、提出解决方案。 •Responsible for presenting processes or documents in inspection and audit, closing compliance gap, close audit/inspection findings. Be familiar with SOPs that impact department, prepare to be ready for ISO/GMP inspections at any time. Ensure all activities in QC CDP are in compliance with regulatory and standards. 负责在审计和检查时介绍相关工作流程和文件，支持质量合规相关工作。熟悉部门相关的所有SOP；为ISO/GMP的检查随时做好准备；确保QC CDP部门的所有活动符合法规和标准。 •As local SOP author, write and update QC CDP related SOPs according to plan. Review and comment on SOPs that may impact own department. 做为本地SOP作者，按计划编写并更新QC CDP领域相关的SOP。负责对会影响本部门的SOP进行审阅并给予意见。 •Perform training coordination within QC CDP team, which include doing process confirmation related to team training works, training other employee to do inspection. 在QC CDP部门内执行培训协调，包括：对部门内的日常培训工作进行过程确认、培训其他员工实施检验工作。 •Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations. 维护安全的工作环境并且按照所有诺和诺德和中国当地安全和环境法规工作。 •Keep line manager accurately informed of work status as well as any problems 保证将工作状态和所有问题准确通知到直线经理 •Be familiar with Chinese GMPs and regulatory requirements related to testing methods and laboratory 熟悉关于测试方法和实验室的中国GMP和相关法规要求

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