General Mission职责概述 • Ensure that the site’s LIMS system is deployed according to Sanofi’s system, ensuring compliance with quality, documentation and GMP and environmental/safety/health requirements 在 LIMS项目主管的带领下，确保工厂LIMS系统按赛诺菲的体系部署，确保符合质量、文件记录和GMP以及环境/安全/健康的要求。 • Operate QC analysis in compliance with analytical methods, Assuring quality, Good Documentation Practices, cGMP, safety health and environmental standards are met. 按照分析方法操作理化实验，确保符合质量、文件记录和GMP以及环境/安全/健康的要求。 • Constitutes standard operating procedures, analytical methods and perform the equipment qualification. 制定标准操作规程和分析检验方法，并执行设备的确认。 Activities具体职责 • Ensure that the LIMS project deployed meets the requirements of local regulations and GMP. 确保部署的LIMS项目符合当地法规和GMP的要求。 • Ensure that the LIMS project deployed can lead the quality control schedule and capacity planning to support the timely release of products and the adherence of the test’s execution to the committed standard times. 确保部署的LIMS项目能领导质量控制计划和产能规划，以支持及时释放产品并遵守承诺的标准时间执行测试。 • Ensure that the LIMS project deployed can define and maintaining the maintenance, qualification and calibration plans to ensure valid status of the lab equipment. 确保部署的LIMS项目能定义和维护维修、确认和校准计划，以确保实验室设备的有效状态。 • Ensure that the LIMS project deployed can handle sample management flows from sampling to receiving and dispatching to the appropriate labs (including stability and EM sample management per plan). 确保部署的LIMS项目能处理从取样到接收和发送到适当实验室的样品管理流程（包括按计划进行稳定性和 EM 样品管理）。 • Ensure that the LIMS project deployed can manage reference standards and reagents for the labs. 确保部署的LIMS项目能管理实验室的对照品和试剂。 • Implementation and maintenance of QC digital solution (core model and local) (including data management and end-user management). 实施和维护 QC 数字解决方案（核心模型和本地）（包括数据管理和最终用户管理）。 • Analysis of raw materials, semi-finished, finished products, validation sample and project sample according to the analytical methods and pharmacopoeia requirements. 按照分析方法及药典的要求进行原辅料，半成品，成品，验证样品和项目样品的检验。 • Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified. 确保他/她接受过培训并具备指定分析测试所需的资格。 • Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed schedules plans. 及时对其他分析员执行的测试进行质量控制数据审查，确保遵守承诺的时间表计划。 • Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately. 及时向其经理通报任何质量或 HSE 事件（偏差、 OOx等），以确保适当进行调查和影响评估。 • Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately. 积极参与其所涉及的任何调查，以确保调查和影响评估得到适当进行。 • Executing assigned CAPAs related to remediation plans, continuous improvements. 执行与补救计划相关的指定 CAPA并持续改进。 • Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately. 确保他/她的实验室/设施、实验室仪器保持质量和安全状态，以确保它们能够得到适当使用。 • Implements the maintenance/validation/verification of laboratory equipment in compliance with the established schedules and maintain accurate records and documentation. 按计划对QC 实验室仪器进行维护、校准并准确记录和存档。 • Support the QC Supervisor with writing draft procedures, draft qualification protocols of the analytical instruments and the analytical methods. Perform the qualification work. 协助QC主管编写标准操作规程、仪器确认草案及分析方法验证方案。进行确认工作。 • Strictly obey the laws and regulations related to the safety management of psychotropic drugs. Perform job operations according to the company's management procedures for psychotropic drug; report any abnormalities promptly. Attend psychotropic drug safety management training on time and pass the assessment. 严格遵守特殊药品安全管理有关的法律法规。 按照公司的特殊药品的管理规程进行岗位操作；发现异常及时上报。 按时接受特殊药品安全管理培训并通过考核。 • To be the backup of the other analysts in case of absent. 其它分析员缺席时作为替补。 • Be responsible for HSE in his/her position and job. 对本岗位的职业健康安全环境工作负责。 • Other works assigned by the leader. 上级安排的其他工作。

• Experience: More than two years working experience in QC. Be familiar with chemical analysis and have experience in analytical method and instrumental validation,including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements. 工作经验: 两年以上QC工作经验，熟悉QC 理化分析, 有分析方法和仪器验证工作经验，包括良好生产规范 (GMP) 和监管要求的知识。 • Soft skill: Familiar to cGMP and regulation, Familiar to office software, Good communication and transversally cooperation, team leading 通用技能：熟悉现行GMP和法规，熟练应用办公电脑软件，良好的沟通协调能力，团队领导力。 • Technical skill: 专业技能: • Familiar to CHP, Chinese & EU & United state GMP, ICH regulation。 熟悉中国药典，中欧美GMP，ICH等法规。 • Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement. 能够分析复杂的数据和实验室结果以做出明智的决策并找出需要改进的领域。 • Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements. 高度重视细节，以确保测试和报告的准确性并符合监管要求。 • Proficiency in identifying issues and implementing effective solutions to resolve quality control problems. 能够熟练地发现问题并实施有效的解决方案来解决质量控制问题。 • Education: bachelor’s degree above, Pharmacy or related field 教育背景: 本科学位以上，药学或相关专业。 • Languages: Good at English reading, writing，be able to discuss the topics of quality and testing in English. 语言要求: 良好的英语读、写能力，可以用英语探讨质量和检验相关的话题。 • Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi 全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致