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第 1 部分：工作描述信息

Section 1: Standard Job Description Information

职务头衔 Job Title

QC分析师 QC Analyst

职务系列 Job family

质量 > 质量控制 Quality > Quality Control

职务概要 Job profile

质量控制理化检测 Quality Control Physico-Chemical Testing

第 2 部分：关于工作

Section 2: About the Job

主要职责 Main Accountabilities

·       及时执行分析测试，确保遵守承诺的计划 Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans

·       根据 cGMP 和 HSE 要求以及与这些任务相关的关联指示、程序、记录执行其任务 Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks

·       记录与任务相关的所有预期原始数据、计算、信息，以符合 cGMP 和数据完整性要求 Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements

·       确保接受培训，并符合要求进行资格鉴定的指定分析测试的资格 Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified

·       及时对其他分析师执行的测试进行 QC 数据审查，确保遵守承诺的计划 Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans

·       及时将任何质量或 HSE 事件（偏差、OOx 等）告知其经理，以确保适当执行调查和影响评估 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

·       积极参与任何调查，以确保适当执行调查和影响评估 Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately

·       执行与补救计划、持续改进相关的指定 CAPA Executing assigned CAPAs related to remediation plans, continuous improvements

·       确保实验室/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。 Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.

第 3 部分：主要参与的决策过程

Section 3: Key involvement in Decision Making process

关键角色（决定/D，A，分享/I）Key roles (D,A,I)

·       制定与检查准备差距、发现、偏差相关的补救计划......（A） Build remediation plans related to inspection readiness gaps, findings, deviations, … (A)

第 4 部分： 职位要求

Section 4: Requirements/Qualifications for job posting

期望技能Expected Technical skills

• 数据分析能力 • 能够分析复杂数据和实验室结果,做出明智决策并识别改进领域Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement

• 细节关注度 • 对细节高度关注,以确保测试、报告的准确性以及符合法规要求 Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements

• 问题解决能力 • 熟练识别问题并实施有效解决方案来解决质量控制问题 Proficiency in identifying issues and implementing effective solutions to resolve quality control problems

语言要求 Language

中文和英文 Local language and English

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Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

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