Ensure that all non-active medical device design control activities meet applicable regulatory / national standard requirements and Fresenius Medical Care processes are being followed. Ensure that all medicinal product development activities meet applicable regulatory / national standard requirements as well as Fresenius Medical Care processes are being followed. Ensure current Good Manufacturing Practices (cGMPs) for both pharmaceutical and medical device are reflected, processed and implemented in daily work to fulfil medicinal product and non-active medical device design and development requirements. Tasks performed regularly which form the essential characteristics of the position. 确保所有非主动医疗器械设计控制活动符合适用的法规/国家标准要求，并遵循费森尤斯医疗流程。 确保所有药品开发活动符合适用的法规/国家标准要求，并遵循费森尤斯医疗流程。 确保药品和医疗器械现行良好生产规范(cgmp)在日常工作中得到反映、处理和实施，以满足药品和非活性医疗器械的设计和开发要求。  Design and Development for Pharmaceutical and Non-active Medical Device (NAMD): o Works as part of product development team on new product development or on design changes to ensure product quality and reliability, minimize risk to users and patients as well as regulatory and corporate SOP compliance. o Reviews and approves design and development deliverables along the product development process as well as design changes. o Reviews and approves Technical Reviews, Design Reviews and Phase Exit Reviews. o Reviews and approves Design Transfer and Technology Transfer Plans, Checklist / Reports. o Guides engineering teams through the product development and design change process in a compliant and efficient way. o Reviews and approves registration relevant lab documentation and product development deliverables o Provides training on Design & Development relevant quality requirements. 制药和非活性医疗器械(NAMD)的设计和开发: 作为产品开发团队的一员，参与新产品开发或设计变更，以确保产品质量和可靠性，最大限度地降低对用户和患者的风险，并遵守法规和公司的SOP。 在产品开发过程中审核和批准设计和开发成果，以及设计变更。 评审和批准技术评审、设计评审和阶段退出评审。 审核和批准设计转让和技术转让计划、清单/报告。 以合规和高效的方式指导工程团队完成产品开发和设计变更过程。 审核和批准注册相关实验室文件和产品开发成果 提供设计和开发相关质量要求的培训。  QMS for Pharmaceutical & Non-active Medical Device: o Support local process owner to create / update local QMS documents. o Create / update local QMS documents. o Review local QMS documents.  Sterile Fluids Lab Management: o Support quality supervision of the pharmaceutical & NAMD lab management. o Review and approve lab management records, include but not limit to instrument / equipment, computerized systems, materials, reagents, reference standards. 药品和非活性医疗器械的质量管理体系: 支持本地工艺负责人创建/更新本地质量管理体系文件。 创建/更新本地质量管理体系文件。 审核当地的质量管理体系文件。 无菌液体实验室管理: 支持制药和NAMD实验室管理的质量监督。 审核和批准实验室管理记录，包括但不限于仪器/设备、计算机系统、材料、试剂、参考标准。  Deviation, Nonconformity (NC) /CAPA: o Provide inputs on the deviations, NCs / CAPAs from quality and regulatory perspective, review corresponding records for Design & Development, lab operations. o Acts as quality approver of deviations, NCs / CAPAs. o Acts as a Quality Assignee for system / process related topics.  Audit: o Support facilitators for internal and external audits. o Acts as an auditee for design & development relevant chapters  Lab Investigation: o Provide inputs on Out of Specification (OOS), Out of Trend (OOT) and Out of Expectation (OOE) lab investigation from quality and regulatory perspective, review corresponding records. 偏差、不符合(NC) /CAPA: 从质量和法规的角度提供偏差、不合格品/ capa的输入，审核设计和开发、实验室操作的相应记录。 作为质量偏差、不合格评定/纠正措施的审批人。 作为系统/过程相关主题的质量委派。 审计: o为内部和外部审计提供支持。 作为设计和开发相关章节的审核员 实验室调查: 从质量和法规的角度对不符合规格(OOS)、不符合趋势(OOT)和不符合期望(OOE)的实验室调查提供意见，审核相应的记录。 2) Secondary tasks: Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position.  Supplier Quality Management: o Performs onboarding activities for suppliers providing goods or services to CC&V. o Manages quality checks and monitoring of the OEM suppliers, lab services for CC&V.  Monitoring and Continuous Improvement: o Tracks quality KPIs for continuous improvements and provides quality performance and trending to Vertical o Drives continuous improvement in the area of quality processes, tools and methods in close alignment with the central SysQaRa unit. o Prepares and conducts regular quality review meetings. o Provides input to Management Reviews. 3) Miscellaneous tasks: Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work. 在主要职责之外经常执行的任务，但这些任务不能决定该职位的基本特征。 供应商质量管理: 为CC&V提供货物或服务的供应商执行入职活动。 管理OEM供应商的质量检查和监控，CC&V的实验室服务。 监测和持续改进: 跟踪质量关键绩效指标，持续改进，提供质量表现 不经常执行但仍是工作的一部分的任务，或特殊任务/项目工作。

Qualifications, experience, know-how and skills critical for success* 1) Required training and education: • Bachelor’s or Master’s degree in pharmaceutical area. 2) Required professional experience (in years): • 3 or more years’ experience in areas of chemical, manufacturing and control in pharmaceutical industry. • 3 or more yeas’ experience of quality assurance. 3年或以上在制药行业的化学、制造和控制领域的工作经验。 3年以上质量保证工作经验。 3) Important personal qualities: • Can work easily with a diversity of people • Skilled communicator • Enjoys leading change efforts • Delivers results even in tough situations •能轻松地与不同的人一起工作 •善于沟通 •乐于领导变革工作 •即使在困难的情况下也能取得成果