8000-10000元
江苏西普拉制药有限公司
1.Review
laboratory controls before release of raw materials/ excipients/ packaging
materials/ finished product. Ensure any errors or deviations have been fully
investigated and acted upon as appropriate. 对原料/辅料/包装材料/成品进行放行前审核。确保对任何错误或偏差进行充分的调查并采取适当的行动。
2.To
release or rejected raw materials/ excipients/ packaging materials/ finished
product.
1. To
ensure that all OOS/OOT/OOAL/OOAC of laboratory have been investigated and
handled timely.
确保所有OOS/OOT/OOAL/OOAC已经过调查并得到及时处理。
2. Maintenance
Deviation handling system. Coordinate risk assessment for deviation and
review corrective actions for deviation. Ensure close deviation in time.
维护偏差处理系统。协调偏差风险评估,审查偏差纠正措施。确保及时关闭偏差。
3. Maintenance
CAPA system. Follow up CAPA status. Ensure close CAPA in time.
维护CAPA系统,跟踪CAPA状态。确保及时关闭CAPA.
4. To review
the change controls related to the quality control.
审核关于QC的变更。
5.
Control
Documents and records, ensure effective version for QC and MICRO.
正确及时有效地执行对文件的管理以保证和理化和微生物实验室使用正确的文件和记录。
6.
Issue QMS number and documents, maintain the logbooks,
and finish the trend of non-conforming events every year.
发放QMS文件编号和文件,维护台账,每年进行不符合事件的趋势回顾分析。
1.Review laboratory documentation
such as test records, audit trail, electronic data, analytical methods, specifications, SOPs and Non-conformity
investigation reports to ensure compliance.
对实验室文件,如测试记录,审计追踪,电子数据,分析方法,质量标准,SOP,不符合项调查报告等进行审核,确保文件的合规性。
2. Follow up all instrument calibration plan,
maintenance plan, water sampling plan, environmental monitoring plan, gas
detection plan, dressing qualification verification plan, clock calibration
plan, stability sampling plan, etc., to ensure that the activities are
completed as planned and on time.
跟踪所有仪器校验计划、维保计划、水的取样计划、环境监控计划、气体检测计划、更衣资质确认计划、时钟校准计划、稳定性取样计划等,确保活动按计划按时完成。
以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕