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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