职位描述
QA审核QCGMPGSP货运/物流/仓储
主要负责产品的释放,确保符合所有适用的GMP/GSP标准和公司GQS的要求;定期进行仓库现场检查以确定整个系统符合要求;并要求对检查过程存在问题或缺陷提出改进意见。
1. 负责对公司的产品执行进库检查放行和/或仓间转移放行。
To be responsible for product verification and release on incoming commercial products and/or
shipment release between warehouses of company.
2. 负责公司储运相关GSP服务商的现场监督管理, 确保其质量体系满足GSP的要求。
To be responsible for warehouse and distribution related GSP Service Providers quality on-site oversight,ensuring the quality system of the provider can meet GSP requirements.
3. 负责对产品的包材等变更进行仓库现场复核或检查。
To be responsible for verification of PPM etc.changes in the warehouse.
4. 负责对包装定制操作按照方案对仓库进行现场培训,并对仓库的包装执行现场操作监督。
To be responsible for on-site training on the product customization to the warehouse operators based
on protocols, and execute on-site oversight on the packaging operations by warehouse people.
5. 协助产品相关的偏差调查处理及变更管理。
Assistance of conducting the investigation and handling of deviation related to the
commercial product, and change controls.
6. 协助确认供应商的月度KPI 考核指标。
Assistance of monthly KPI checking of service providers.
7. 完成主管要求的其他工作
Complete other tasks assigned by supervisor
Minimum Qualification Requirements:
Bachelor degree or above, majored in pharmaceuticals, chemistry, biological, medical etc.
related sciences
本科或以上学历,药学,化学,医学,生物学等相关专业
至少1年的药品或者医疗器械质量经验
One year of Quality experience in pharmaceutical or medical device field
Capable of reading and writing in English in fluency
能熟练用英语阅读和书写
Other Information/Additional Preferences:
Excellent communication (written and verbal), self-motivated and proactive,serious and careful
良好沟通能力(书面读写流利),积极主动,认真细心
Strong knowledge of quality systems (e.g. GSP regulation and basic knowledge about testing of QC lab )
扎实的质量知识( 比如对GSP法规的了解,基本的QC实验室检验的知识)
1. 负责对公司的产品执行进库检查放行和/或仓间转移放行。
To be responsible for product verification and release on incoming commercial products and/or
shipment release between warehouses of company.
2. 负责公司储运相关GSP服务商的现场监督管理, 确保其质量体系满足GSP的要求。
To be responsible for warehouse and distribution related GSP Service Providers quality on-site oversight,ensuring the quality system of the provider can meet GSP requirements.
3. 负责对产品的包材等变更进行仓库现场复核或检查。
To be responsible for verification of PPM etc.changes in the warehouse.
4. 负责对包装定制操作按照方案对仓库进行现场培训,并对仓库的包装执行现场操作监督。
To be responsible for on-site training on the product customization to the warehouse operators based
on protocols, and execute on-site oversight on the packaging operations by warehouse people.
5. 协助产品相关的偏差调查处理及变更管理。
Assistance of conducting the investigation and handling of deviation related to the
commercial product, and change controls.
6. 协助确认供应商的月度KPI 考核指标。
Assistance of monthly KPI checking of service providers.
7. 完成主管要求的其他工作
Complete other tasks assigned by supervisor
Minimum Qualification Requirements:
Bachelor degree or above, majored in pharmaceuticals, chemistry, biological, medical etc.
related sciences
本科或以上学历,药学,化学,医学,生物学等相关专业
至少1年的药品或者医疗器械质量经验
One year of Quality experience in pharmaceutical or medical device field
Capable of reading and writing in English in fluency
能熟练用英语阅读和书写
Other Information/Additional Preferences:
Excellent communication (written and verbal), self-motivated and proactive,serious and careful
良好沟通能力(书面读写流利),积极主动,认真细心
Strong knowledge of quality systems (e.g. GSP regulation and basic knowledge about testing of QC lab )
扎实的质量知识( 比如对GSP法规的了解,基本的QC实验室检验的知识)
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