上海招聘

1. 编制公司产品（容器、模块和制药工程项目）验证文件（IQ、OQ、PQ等）；

   Draw up validation document (IQ、OQ、PQ and more) for company production(vessel，process module and pharmaceutical project)

2. 审核公司产品有关的FAT、SAT、质量证明文件的符合性；

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

3. 参与编制和翻译验证咨询项目验证咨询文件、培训和指导客户验证活动实施；

   Translating and Preparing validation consulting project 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年以上药厂和制药工程工作经验，2年以上验证工作经验

   Over three years work experience in pharmaceutical manufacturing or engineering and over two years validation experience

2. 熟悉制药工程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. 具有压力容器、管道、焊接或HVAC等相关专业工程技术标准和规范及制造、检验知识

   With knowledge of the manufacturing，inspection of pressure vessels, piping，welding or HAVC etc.

4. 工程类本科以上学历

At least bachelor degree majoring in Engineering or related.

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.

2. 能经常出差

   Frequent travel will be required.
   

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