respoibility:

职责

1.to colaborate in projects on gmp compliance of drug products and api

参与并完成制剂以及api的gmp符合性项目

2.process validation for drug products and api , computerized systems validation , cleaning validation, analytical method validation, facilities & equipments commissioning and qualification

制剂与api工艺验证、计算机系统验证、清洗验证、分析方法验证、厂房&设备试运行与确认

3.to collaborate in projects to impelment quality systems according to gmp requirements

根据gmp要求，参与并完成关于质量体系实施的项目

4.collaboration in performing training coues to custome

为客户提供培训课程

5.collaboration in preparation of regulatory affai documentation

编写法规注册文件

6.to perform gmp audit

开展gmp审计

requirements:

要求

1.chemical engineer, chemist or pharmacy

化学工程师、化学或药学专业

2.at least 3 year working in organization under gmp compliance or similar

至少3年以上gmp符合性或类似部门的工作经验

3.be fluent in spoken and written english

英语口语流利，书面英语良好，能用英语与西班牙同事沟通

4.available for short term business trip

能适应短期出差

5.work experience in pharmaceutical companies is preferred. male is preferred.

有药厂工作经验者优先，***。