Job responsibility 工作职责
Laboratory equipment 实验室仪器设备
61 Perform and/or support equipment and QC support systems, ensure the lab is in clean status;
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 compendial method: ID testing, physical and chemical test, bacterial endotoxin and microbial limit testing;
执行药典常规方法：鉴别测试、理化测试、细菌内毒素和微生物限度测试；
61 Be familiar with basic testing methods of raw material;
熟悉相关原辅料基本检测方法；
61 Initiator and review 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；
61 Good time management skills to ensure smooth implementation of projects.
具有很好时间管理能力，以确保项目的顺利实施。
Data Management 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 According to different pharmacopeia, do gap assessment for material.
依据不同的药典，对物料进行差距分析。
General 常规要求
61 Comply with general Company Policies and Procedures.
遵守公司政策和程序；
61 Assist superiors to complete other work if needed.
如需要协助上级领导完成其他相关工作
Safety and environment 现场安全和环境合规
61 Ensure personal conduct is safe and compliant, participate in and maintain a safe work environment;
确保个人行为安全合规、参与并维护安全的工作环境 ；
61 Adhere to the Company’s safety and environmental protection procedures.
遵守公司的安全环保程序
Quality Assurance 质量要求
61 Comply with the Company 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, deviations, OOS and Risk assessment, etc.);
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、偏差、OOS和风险评估等） 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。