上海招聘

职位描述：
responsibility:
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 courses to customers
为客户提供培训课程
5. collaboration in preparation of regulatory affairs 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，***。 举报 分享

TDV is a Spanish Company, with headquarter located in Barcelona, Spain and branch company located in Shanghai. TDV is a leading company in technological and regulatory consultancy for the pharmaceutical and chemical-pharmaceutical fields especially in quality and regulatory aspects (GMP, GLP, GCP). We provide professional services including: GMP audits, preparation of regulatory documentation(DMF, CEP,…), preparation of US FDA and EU regulatory inspections, training services, design and qualification of facilities, process validation, computerised systems validation,…to our international customers in EU, Asia…
TDV是一家西班牙企业，总部位于西班牙巴塞罗那。上海韬维医药咨询有限公司为其子公司。TDV在制药和化学领域的技术和法规咨询服务处于行业领先地位，尤其是质量和法规方面，包括GMP、GLP、GCP。公司为国际客户（包括欧洲、亚洲等）提供的专业服务包括： GMP审计、编写法规文件(DMF、CEP等)、备战US FDA和EU法规检查、培训服务、厂房设计与确认、工艺验证、计算机化系统验证等。