Sr. Associate-Quality Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Monitor, verify and provide quality oversight for drug products throughout receiving, storage and distribution processes; promptly report quality issues to the supervisor and ensure timely handling.
对药品收货、验收、贮存和发运等全过程进行日常质量监督、检查和指导；对发现或反馈的质量问题及时向主管汇报并推动妥善处理。
Responsible for the translation and management of CoA, ensuring accurate and timely delivery of translated reports to warehouse verification personnel; manage and continuously improve the product release process, review inbound product documentation and records, and complete product release activities in electronic systems and paper-based records in a timely manner, ensuring compliance with GSP requirements and Lilly standards.
负责原厂检验报告的翻译及其管理，确保译文准确、及时传递给仓库验收人员；负责产品放行流程的管理和持续优化，审核入库产品相关文件及记录，并及时在电子系统和纸质记录中完成产品放行，确保符合GSP及礼来要求。
Responsible for investigating and managing deviations or quality events related to MIC products, ensuring that event handling complies with Lilly GQS requirements, and effectively following up on corrective and preventive actions.
负责MIC产品相关偏差或质量事件的调查和管理，确保事件处理符合礼来GQS要求，并有效跟踪纠正和预防措施的实施。
Review and make quality decisions on returned and rejected products and provide oversight of the handling process for returned and rejected products.
负责退回产品和不合格产品的质量审核与判定，并对退回及不合格产品的处理过程实施监督。
Review and make quality decisions on returned and rejected products and provide oversight of the handling process for returned and rejected products.
负责退回产品和不合格产品的质量审核与判定，并对退回及不合格产品的处理过程实施监督。
Collect quality information monthly as backup support, report MIC quality KPI metrics, perform monthly on-site oversight of the MIC warehouse, issue oversight reports and follow up on required actions.
每月收集质量信息（作为后备人员支持），负责报告MIC质量KPI指标；每月对MIC仓库进行现场质量监督，出具监督报告并跟踪相关整改措施。
Responsible for drafting and revising SOPs related to assigned responsibilities.
负责起草和修订职责范围内相关的SOPs。
Prepare and execute periodic warehouse temperature mapping and temperature/humidity monitoring system validation to ensure warehouse conditions meet product storage requirements.
负责准备并执行MIC仓库温度分布测试及温湿度监测系统的定期验证，以确保仓库温湿度条件符合产品贮存要求。
Provide quality oversight of calibration, validation and qualification activities for MIC warehouse facilities, utilities and equipment, and develop annual maintenance plans and validation master plans for relevant systems.
对MIC仓库设施、公用系统和设备的校准、验证及确认活动提供质量监督，并制定相关系统的年度维护计划和验证主计划。
Ensure the security of specially controlled products and other products, where applicable.
确保特殊管理产品及其他产品的安全管理（如适用）。
Serve as Business QA for computer systems by coordinating and participating in related activities, including user requirements, validation, supplier management and change control.
作为计算机系统业务质量代表，协调并参与相关活动，包括用户需求、验证、供应商管理和变更控制等。
As backup, perform quality management for MIC consignment warehouses in other provinces, including product batch release at regional distribution centers.
作为后备人员，负责MIC省外委托仓库的质量管理，包括区域分销中心的产品批放行。
As backup, serve as coordinator for external third-party quality management, overseeing the end-to-end GMP service provider management process, including risk assessment, change control, qualified supplier list development, coordination of corporate supplier audits, periodic quality assessments, quality agreements, maintenance of records and documents, supplier list maintenance and TPO system activities.
作为后备人员，担任外部第三方质量管理协调人，负责端到端的GMP服务供应商管理流程，包括风险评估、变更控制、合格供应商清单制定、协调总部供应商审计、定期质量评估、质量协议、记录和文件维护、供应商清单维护及TPO系统相关活动等。
Perform other tasks assigned by the supervisor.
完成主管安排的其他工作。
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