QC

主要职能：

建立分析仪器验证方案并完成报告。
Design analytical equipment qualification protocol and complete report.
✓ 负责实验室设备的管理，确保设备的验证和使用符合中国 GMP 和公司 GQS605 的要求。
To take responsibility for laboratory analytical equipment installation, and make sure the equipment qualification activities should be complied with both Chinese GMP and GQS605 requirement.
✓ 起草部分设备验证方案、预防性维护方案、校验方案。起草部分设备操作规程。
To prepare some equipment qualification protocol, preventive maintenance, calibration protocol and working instruction.
✓ *根据 GMP 要求有序，有组织地书写验证报告和其它文件。
To prepare the verification reports and other documents in order and organized format according to the GMP requirement.
• 负责分析仪器的初始验证，再验证。
Responsible for analytical equipment initial qualification/re-qualification.
✓ 在期望的时间内根据批准的验证方案（英文）来进行实验室设备验证工作。
To perform lab equipment qualification according to the approved qualification protocol (English) within the desired lead time

制定年度内部和外部校正计划，仪器设备的更新计划及其他设备管理相关事务。
Respond to maintain annual internal and external instrument calibration plan, equipment & instrument replace plan, and other activities for equipment & instrument in lab.
✓ 根据规程的要求，预先对设备和仪器进行校正保养和维修保养。协调设备的计量校验。
To perform the equipment calibrations and maintenance according to the procedures on a preplanned schedule. Coordinate the equipment calibration.
• 协助 GLIMS 系统实施。
To assist with GLIMS deployment.
• 做其他与质量相关的事项。
To assume other tasks related to Quality.
✓ 协助实验室质量体系的持续改进提高。
To assist with lab quality system continuously improvement.
• *遵守 HSE 各项管理流程，履行安全生产职责要求。
Follow various HSE management procedures and fulfil the work safety responsibilities