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.
岗位描述 Position Description:
该岗位为工厂合规QA，负责通过构建、完善、执行和监督质量流程来保障工厂质量体系的全面合规性。持续监督本地法规、药品生产质量管理规范以及礼来公司全球质量准则要求的实施，并按适当的管控措施及时上报潜在合规性风险。
This role serves as site Compliance QA, is responsible to ensure the overall compliance of the site quality systems by building, improving, executing and monitoring strong quality process. To monitor for compliance with local regulations, the requirements of GMPs and Lilly Global Quality Standard, and report potential compliance risk in a timely manner through appropriate governance.
主要职能 Key Objectives/Deliverables:
负责协调外部GMP审计和礼来总部质量审计，作为审计准备小组的成员，支持审计准备；跟踪审计整改回复和具体行动项的实施。
Be responsible for coordination of external GMP audit and Global Quality Audit, as Inspection Readiness team member, to support inspection readiness prep; follow up the response preparation and action implementation.
负责维护工厂质量合规相关文件，包括质量手册、场地管理文件、质量体系的管理评审以及工厂合规报告等。
Be responsible for maintaining documentations relevant to the quality compliance, including Site Quality Manual, Site Master File, Management Review of Quality System, Site Compliance Report, etc.
负责协调工厂质量管理层会议议题的收集并记录会议纪要。
Be responsible for coordinating the collection of Site Quality Lead Team Meeting topics and recording meeting minutes.
协助构建稳健的工厂质量体系，参加总部会议、与其他工厂交流最佳实践，以支持工厂合规体系的持续改进。
Assist to establish the robust site Quality System, participate in global team conference continuously improve the compliance system.\\
作为自检协调员
As SSI Coordinator Role
Maintain the for SITE SELF INSPECTION, to ensure compliance with the requirements from Lilly and Intended markets regulations.Coordinate the annual SSI Plan development and approval and follow up the implementation.SSI Assessor参与公司自检。Participate in the site self- inspection program as SSI Assessor.
其他与质量管理相关的事项，如：
To assume other tasks related to QA, such as:
To provide good services and recommendations to other departments for improvement完成主管安排的其他任务
Other jobs assigned by supervisor
遵守HSE各项管理流程，履行安全生产职责要求。
Follow various HSE management procedures and fulfil the work safety responsibilities.
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