CSV Consultant
Location: SwitzerlandSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Genf Switzerland.
You will be working within an international environment on multiple CSV projects.
ROLE DESCRIPTION
As the CSV Consultant you will be responsible for several validation projects according to international quality standards and guidelines (GAMP5 / FDA / EU). You will develop protocols (IQ/OQ/PQ) and write several risk assessments. Furthermore you will collaborate with the validation team in order to execute according to the company’s quality standards and you will train the end-users.
We are looking for a freelance CSV specialist who is available to start on the 16th of May for a project until the end of the year. After this project there is a good chance of extension for another six months.
RESPONSIBILITIES
- Execution of multiple validation projects according to international guidelines and standards
- Development of installation protocols (IQ / OQ / PQ)
- Write master validation plans according to international guidelines and standards (FDA / GMP / EU)
- Development of SOPs
- Training of end-users
- Configuration and testing of multiple business applications
- Implementation of new business applications
REQUIREMENTS
- Strong knowledge of computerized systems validation processes (GAMP5 / EU / FDA)
- Senior experience with development of protocols (IQ / OQ / PQ)
- Previous experience in the Medical Devices, Pharmaceutical or Biotechnological industry
- Previous experience with master validation plans
- Knowledge of Risk Assessments
- Fluency in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hayo Gerbranda.
