上海招聘

Responsibility:

职责

1. To colaborate in projects on GMP compliance and validation of computer systems, drug products and API processes, Facilities & Equipments commissioning and qualification

协助完成关于GMP符合性、计算机系统验证、制剂与API工艺验证、厂房&设备试运行与确认的项目

2. To collaborate in projects to impelment Quality Systems according to GMP requirements

根据GMP要求，协助完成关于质量体系实施的项目

3. Collaboration in performing training courses to customers

协助完成为客户提供的培训课程

4. Collaboration in preparation of regulatory affairs documentation

协助编写法规事务文件

Requirements:

要求

1. Chemical Engineer, Chemist or Pharmacy

化学工程师、化学或药学专业

2. At least 2 year working in organization under GMP compliance or similar

2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

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。