Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Main responsibilities职责描述：
Please indicate here the main job responsibilities请列举该职位的主要工作职责。
General Mission职责概述
•    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
•    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。
•    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。
•    Maintain the reference standards as well as the relevant documentation and record.  Maintain the reagents and their records. 
负责对照品的管理及记录。负责试剂的管理及记录。
•    Support the QC Supervisor with writing draft procedures, draft qualification protocols of the analytical instruments and the analytical methods. 
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。
•    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。

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.