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.
作为微生物专家，对实验室运转，方法转移，方法确认，方法验证等提供技术支持。保障核心技术发展以及实验室和方法的合规。参与方法资质认定 （转移，确认，验证）。作为总部，注射用药物的产品网络以及区域工厂实验室之间的联络人员，促进信息的传达和更优措施的分享。
Provide technical support to Laboratory operations and method transfer, verification or validation activities. Ensure technical development of key resources and maintain Labs and methods in compliance. Participate in method qualification approach identification (validation, transfer, verification). Be the liaison between Global, PPN and Site Laboratory resources to facilitate the transfer of information and sharing best practices among the Sites.
日常支持 Daily Support
当分析活动出现问题或偏差时，作为主要调查人员进行实验室分析调查并确认根本原因。
Provide support to Laboratory analytical investigation and root cause identification. Participate as a Lead Investigator in Laboratory incidents/deviations (If needed).
参与变更和偏差审核会议。
Participate in the Change and Deviation Review Board meetings.
尽快解决技术问题，以确保分析活动可以在规定时间内完成。
Help to meet analysis cycle time requirements by solving in a quickly manner any technical issue or situations.
参与实验室各类指标的审核，确保实验室的各项活动可以高效运转并持续优化。
Participate in Labs metrics reviews. Helps Lab to identify trends, focus on continuous improvement and drives operational excellence.
技术发展Technical Development
发掘实验室技术人才，衡量其技能水平，与质量控制部门管理人员共同培养年轻人才。
Identify technical talent in the Laboratories, assesses technical capabilities and work in collaboration with QC management to develop them.
根据工厂内部的需求，对主要技术制定技术发展项目。
Creates and maintain a technical development program for major technologies based on common needs across the Site.
合规Compliance
确保质量控制实验室相关的操作规程与相应的标准（全球质量标准和常见质量操作）及法规保持一致。
Ensure that procedures related to QC Laboratories are in compliance with applicable standards (GQS and CQP) and regulations.
确保分析活动符合内部外部的质量和合规要求，确保分析活动及时完成。
Meet internal and external quality and compliance commitments and ensures their timely closure.
负责审评实验室管理报告以及其它由实验室主管指派的报告。
Responsible for the evaluation of Lab Management report and others Lab reports as assigned by Supervision.
与质量控制部门管理人员协同合作，尽可能减少人为错误的发生，以不断强化质量体系。
Collaborate with QC management to identify opportunities to reduce human errors by strengthening the Quality systems.
参与部门内外的审查（法规事务审查/获批前审查）
Participate in external and internal inspections (Regulatory/Pre-Approval Inspection).
参与药品生产质量管理规范审查准备。
Participate in GMP inspections readiness.
参与陪同药品生产质量管理规范审查 （内部和外部）。
Participate during GMP inspection (Internal and external).
帮助纠正不当状况，以避免其在药品生产质量管理规范审查中再次发生。
Help to correct any observations that could occur during GMP inspections.
全球质量标准职责Global Quality Standard Responsibilities
确保有充足的设施，受过培训的人员以及被批准的操作规程可用于测试。
Ensure that adequate facilities, trained personnel, and approved procedures are available for testing.
确保分析测试方法已被验证可以用于相应的检测，且符合全球质量标准“603-分析测试方法”中的相关要求。
Ensure analytical test methods area validated for their intended use in accordance with GQS603 – Analytical Test Methods.
确保分析仪器和系统适用，且符合全球质量标准“605-分析仪器”中的相关要求。
Ensure analytical equipment and systems are suitable for use in accordance with GQS605 – Analytical Equipment.
确保测试操作存在手工记录或仪器记录，用以证明已进行的操作符合全球质量标准 “601-分析测试操作”中的相关要求。
Ensure that records are made manually or by recording instruments, which demonstrate that all the required testing procedures were actually carried out in accordance with GQS601 – Analytical Testing Practices.
确保检查结果被真实记录，且和接收限度严格比对。
Ensure that records are made of the results of inspection and that testing is formally assessed against specification.
确保偏差和超规限度的结果都被完整记录和调查，并符合全球质量标准“104-偏差控制”和“604-分析结果调查”。
Ensure that any deviations or out of specification (OOS) results are fully recorded and investigated in accordance with GQS104 – Deviation Management and GQS604 – Analytical Result Investigations.
确保实验室控制需在实施时遵循相应规范，并被完整记录。
Ensure that laboratory controls are followed and documented at the time of performance.
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.
基本要求 Basic Requirement
本科及以上学历，药学生物学或相关学科
Bachelor’s degree or above, majored in pharmaceuticals, biology or related sciences
具备多种能力，包括协调，发现，判断，修订，预计，评估，面谈，影响，指导，阐释，阅读，协商，观察，计划，编写，搜集信息，组织，监管以及选择。
Capacity to coordinate, detect, diagnose, edit, estimate, evaluate, interview, influence, instruct, interpret, read, negotiate, observe, plan, compile and collect information, organize, supervise, and select.
能流利运用中文和英文进行书面和口语表达交流
Fully Bilingual (Chinese and English) Strong written and verbal communication skills.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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