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晟斯（上海）生物制药有限公司
552
34
7
Location上海·浦东新区, CN China
SalaryCNY 10,000 - CNY 18,000 /month
Experience4 years+
Work TypeOnsite
EmploymentNot specified
Working daysMon - Fri
LevelNot specified

Job Description

1.建立和完善相关CSV管理制度和流程； 2.负责制定审批工厂计算机验证主计划； 3.负责工厂计算机系统的再验证工作， 起草/审批验证方案， 参与和指导实施具体CSV验证； 4.负责新的计算机相关项目的验证管理， 按要求管理合同方按GMP要求完成系统的DQ，IQ， OQ， PQ等相关验证； 5.负责车间、化验室、公用工程涉及CSV内容的设备确认文件的审核、CSV实施过程跟踪、指导、问题的协调解决； 6.负责对公司CSV执行情况进行审计，出具审计报告并跟踪整改审计结果； 7.负责GMP认证、现场核查过程中涉及的CSV相关问题的解释、问卷整改措施的审核及整改情况跟踪； 8.负责CSV和数据完整性法规及指南解读和培训，为生产岗位人员、质量管理人员普及CSV和数据完整性知识； 9.上级交办的其他工作。 任职要求: 1.本科及以上学历，药学类、计算机类相关专业； 2.熟悉CSV工作内容对GMP有一定的了解； 3.具备较好的沟通表达能力和执行力。

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晟斯（上海）生物制药有限公司

晟斯（上海）生物制药有限公司

Chinese biopharmaceutical company established on 24 February 2021 at Liangyao Road in Xinchang town, Pudong New Area, Shanghai with one hundred million yuan of registered capital, part of the Gensciences group whose Jiangsu company was founded in April 2020. The group develops innovative medicines for unmet clinical needs in haemophilia, metabolic disease and oncology and combines innovative drug research, clinical development, manufacturing and commercialisation with research and production bases in Beijing, Zhengzhou and Shanghai. Its long acting recombinant coagulation factor VIII has reached phase three clinical study and an ultra long acting recombinant factor VIII has been filed for clinical trials.

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Job Category

Quality Assurance & Quality ControlPharmaceutical Manufacturing

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