岗位职责:
1.负责实验室检验仪器的管理，包括新仪器的验收，安排仪器维修、定期校准和确认工作。
Responsible for the management of laboratory testing instruments, including acceptance of new instruments, arranging for instrument maintenance, periodic calibration and validation.
2.负责实验室计量器皿，如容量瓶、移液器、温度计的维护和管理。
Responsible for the maintenance and management of laboratory measuring instruments such as volumetric flasks, pipettes, thermometers.
3.管理高价值的仪器、配件。
Manage high value instruments, accessories.
4.协助检测小组对检测设备进行维护保养。
Assist the testing team in the maintenance of testing equipment.
5.监督检测小组正确使用、维护检验设备，同时对设备校准数据进行趋势分析，对设备状态进行评估。
Supervise the testing team in the proper use and maintenance of the inspection equipment, as well as trend the equipment calibration data to assess status of equipments.
6.起草检验仪器确认方案和报告，并参与实施。
Draft validation programs and reports for testing instruments and participate in their implementation.
7.起草分析仪器的操作SOP。
Draft SOPs for operation of analyzing instruments.
8.负责建立及维护CSV系统清单，确保清单保持最新状态； 参与计算机化系统的定期审核。
Responsible for creating and maintaining CSV system inventory and ensuring that the inventory is kept up-to-date. Participate in periodic audits of computerized systems;
9.定期备份实验室电子数据。
Regular backup of electronic laboratory data.
10.参与对计算计化系统的变更进行风险评估，确保变更符合法规要求。
Participate in risk assessment of changes to the computerized system to ensure changes are in compliance with regulatory requirements.
11.参与GMP注册核查等重要检查，负责准备相关迎检资料回答相关问题。
Participate in important inspections such as GMP registration verification and be responsible for preparing relevant welcoming materials to answer relevant questions.
12.组织仪器操作和安全方面的培训。
Organize training on instrument operation and safety.
13.发起检验仪器相关的变更、偏差，并参与相关OOS、偏差的调查。
Initiate inspection of instrument related changes and deviations and participate in the investigation of related OOS and deviations.
14.负责设备使用记录的领用和发放，并对设备使用记录进行日常巡回检查。
Responsible for the receipt and issuance of equipment usage records, and conducts daily walk-throughs of equipment usage records.
15.完成QC主管分配的其他工作和职责。
Any other job and responsibilities assigned by QC supervisor.
任职要求:
1.负责保证所有的活动符合GMP的要求。
Be responsible for assuring that all the activities are in line with GMP requirement.
2.严格按SOP进行操作，并真实地、及时地、准确地完成记录填写和数据处理，及时归档检验记录。
operations in strict accordance with SOPs, and to complete record filling and data processing truthfully, timely and accurately, and to file analytical records in a timely.
3.完成验证相关工作；
Carry out the various necessary validations;
4.协助QC主管，针对仪器操作的内容，对人员进行上岗前培训和继续培训。
Assist QC supervisor to conduct pre-service training and continuous training on operation of instruments or equipments for relevant personnel.
5.参与OOS、偏差调查，以及相关的变更控制；
Responsible for conducting investigations of OOS and deviations and related change control;