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1年经验 -
本科 -
招1人 -
02-03 发布
职位描述
1. Responsible for assisting the QA Manager on any activity related the management of documentation for supplier management such as maintaining the Supplier Management files, tracking, archiving. 负责协助QA经理处理有关供应商文件管理的工作，例如维护供应商管理文件，追踪，归档等。 2. Get involved on all cGMP Import/export Materials, components, Active Drug Substances, and excipients to ensure proper tracking, managing, documentation, and filing. 参与所有的cGMP进/出口物料，组件，原料药和辅料以确保恰当的对其进行追踪，管理，文件编写和存档。 3. 80% support to the Supplier Management team to provide support on the maintaining the Internal/External audit files, and the tracking of the communication with suppliers during the qualification process. 80%辅助供应商管理团队维护内审文件和外审文件以及追踪供应商确认过程中与供应商的沟通情况。 4. Maintain all cGMP site licenses and permit up to date and properly filed. Ensure that applications are submitted before expiration. 维护所有cGMP现场许可，及时更新并恰当存档。确保在过期前提交申请。 5. Provide 20% support to the QA documentation supervisor when required by the QA Manager on documentation activities such as filing, archiving, copying, distribution of documents, obsoleting and destruction of documents. 如QA经理需要，提供QA文件主管20%的支持，例如归档，存档，复印，文件分发，文件废弃及销毁。 6. Coordinate QA meetings such as Change Controls, PDR/MRB, annual reviews, and internal QA meetings. 协调QA会议，比如变更，PDR/MRB,年度回顾及内部QA会议。 7. Responsible for the review of all documentation related to materials released prior production. 生产之前放行物料相关的所有文件的审查。 8. Responsible to support QA Manager on any other activities as deemed necessary. 负责辅助QA经理任何其它必要的活动。 职能类别： 其他
联系方式
海林市海林经济开发区东旭路7号
公司信息
公司总部位于美国加利福尼亚州圣地亚哥，生产工厂位于中国东北部风景优美的黑龙江省。基纳瑞克斯提供包括技术转移、工艺开发、放大实验、设备/工艺验证，配液、灌装、冻干、检验、完整性检测、贴标签及装盒等的整套服务，符合美国食药监局、欧洲药品管理局、中国食药监局及日本法规机构的要求。With our corporate headquarters located in San Diego, California, USA and our manufacturing facility located in the scenic Heilongjiang Province in the north eastern part of China OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulatory
