工作职责包括但不限于: Safety and environment 现场安全和环境合规 61 Promote a culture of safety work place through personal actions; 以身作则推动建立安全的工作环境; 61 Adhere to the Company’s safety and environmental protection procedures. 遵守公司的安全环保程序
Laboratory equipment 实验室仪器设备 61 Manage and perform and/or support equipment and QC support systems, ensure the lab is in clean status管理、执行以及/或支持仪器设备和QC辅助系统,确保实验室处于整洁有序的状态 61 Ensure calibration and maintenance is within expiration date basing before use确保仪器在使用前其计量和/或维护在有限期内 61 Initiate and revise related equipment operation procedure 起草和更新相关仪器的操作流程
Testing 检验 61 Conduct related daily testing, such as microbe limit testing, sterility testing. Daily test, validation work should be added in prefer part执行日常的微生物测试和准备工作,能按质按量的完成相关工作, 61 Conduct cleanroom routine environmental monitoring, purified water system and compressed gas system routine monitoring执行洁净区域和纯化水系统的日常环境监测 61 Draft and review test methods and procedures for completeness and accuracy;起草方法操作规程和其他管理规程,审核其完整性和准确性; Material/Data Management 物料/数据管理 61 Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data;对记录、计算、编辑、解释、审核以及录入数据负责; 61 Responsible for the inventory management of all media, and reagents used in QC testing;对于所有用于检验的培养基和试剂的储存管理负责; 61 Ensure the timely disposal of tested samples and archive of retention samples; 确保及时处理检验样品和样品的留样
Quality Assurance 质量要求 61 Comply with the Company’s Quality Management Systems;遵守公司质量管理体系; 61 Initiate new and revise documents, participate in investigation teams, and provide input to quality systems (change control, CAPA, and deviations); 起草新文件和修订文件,参与调查团队并且在质量体系运营中(变更、CAPA和偏差)提供支持; 61 Comply with GLP and cGMP, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books.遵守GLP和cGMP的要求,包括但不限于:培训记录、实验室记录、书面规程、仪器设备监控系统和实验室工作日志的维护。 General 常规要求 61 Comply with general Company Policies and Procedures遵守公司政策和程序;