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。

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