上海招聘

1. 编制公司产品（容器、模块和工程项目）GAMP5相关验证文件（IQ、OQ、PQ等）；

   Preparing GAMP5 document (IQ、OQ、PQ and more) for company production(vessel，process module and pharmaceutical project)

2. 审核公司产品与GAMP5有关的FAT、SAT、质量证明文件的符合性；

   Review the compliance of FAT/SAT proposal and quality certificates related to GAMP5.

3. 参与编制和翻译验证咨询项目GAMP5/CSV验证咨询文件、培训和指导客户验证活动实施；

   Translating and Preparing validation consulting project GAMP5/CSV document; training and directing client implementation.

4. 指导和督促验证文件的实施，确保文件完整性、准确性

   The internal implementation of the guidance and supervision of the document, to ensure that the file integrity、accuracy

专业技能及经验要求

JOB KNOWLEDGE SKILLS AND EXPERIENCE

1. 3年以上工作经验，计算机验证工作经验优先

   Over three years work experience.

   CSV experience is preferred.

2. 熟悉制药工程GAMP5/CSV验证相关标准和规范（EU, USA, WHO, PIC/S, ISPE and ICH）

   Familiar with the relevant codes and standards of the pharmaceutical engineering (EU, USA, WHO, PIC/S, ISPE and ICH).

3. 自控或计算机类本科以上学历

At least bachelor degree majoring in automation or computer science.

1. 英语阅读、书写流利，能进行制药项目中译英及英译中翻译。

   Good English proficiency in both oral and written. Good skills for Chinese and English translation for pharmaceutical project.

   5 应届毕业生视面试情况录用

   Excellent graduate is also considered after interview.

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