1 根据有效方法对纯化水、产品进行微生物检测。根据SOP对微生物洁净区和生产洁净区的进
行环境监测。
Microbiological tests of the purified water and product in accordance with the valid methods. Environment monitoring of the microbiology testing area and dry processing area in production according to SOP
2 负责所涉及仪器、设备的使用和维护及相关记录。
Maintenance the related instruments and equipments as well as the use log.
3 负责相关仪器的校验和确认。
Responsible for the calibration and verification of related instruments.
4 按照GDP要求记录所有的分析数据。
Record all analytical sheet according to GDP.
5 按照SOP要求完成取样。
Perform sampling according to SOP.
6 负责仪器故障的报告和处理
Responsible for reporting the malfuncation and handling.
根据SOP要求向部门主管报告任何可疑结果 Report the doubtful results to the QC officer.
7 遵守 GLP,cGMP
Follow-up the GLP, cGMP in laboratory.
8 公司安排的其他任务。