(Sr./Principal)Associate-QABatchRelease

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: 负责维护湖东制造工厂产品的批放行管理流程并确保按照要求完成产品的放行活动。 Responsible for maintaining ELM site product’s batch disposition program and ensure s are released according to this program. 执行生产过程的现场质量监管，确保整个生产过程和产品质量得到控制并符合所有适用的标准要求。 Perform on site quality oversight for manufacturing process and ensure all process and product quality are in control and complaint to all applicable standard requirements. Responsibilities: * 作为QA代表参与PMX项目 Participant in the PMX project as QA representative * 按时参与日常的会议，从质量角度提出必要建议和改进要求 Attend the regular meeting on time, and provide the suggestion from quality * 确保PMX项目的实施符合GQS和GMP的要求 Ensure the implementation of PMX complain with GQS and GMP requirement * 与质量团队沟通项目中问题并收集、反馈来自质量团队的需求 Communicate the progress of the project within Q group and coordinate the comments from Q if needed * 审核所有PMX项目相关的文件 * Review all project related documents Basic Requirements: * 作为质量代表参与SAP项目（不包含来料释放部分） Quality representative for SAP system (incoming material release process is not included). * 作为质量代表参与ELM SAP项目，参与SAP流程设计和改进 Participate in Suzhou ELM SAP design and improvement as the role of quality representative. * 作为质量代表提供物料和产品所需的QM主数据 Be responsible for providing master data for semi-finished products or material as SAP quality representative * 负责胰岛素半成品和培养基灌装批次的释放 Be responsible for batch release of semi-finished insulin products and media fill batches * 审核所有批释放相关的文件，确保数据完整和真实 To review all batch records and relate