Description
I am currently looking for a CSV consultant for a 6 month project in the Geneva area. My client is an international, well established, leading life science company. The position requires the following skills:Skills:
- Execute several Software Validation projects in accordance with corporate IT/Quality standards, and industry standards (ISO 13485, 21 CFR 820, 21 CFR 11, GAMP 5) within the medical device department:
- Write validation plan, URS, FS, risk assessment. Get approved by System Owner and QA.
- Write IQ/OQ/PQ protocols, reports, VSR. Execute testing in collaboration with local validation team.
- Write applicable SOPs and training documents.
Types of systems:
- Automated software testing tools.
- Software configuration/testing/deployment management Tools.
If you are interested please feel free to contact me, to discuss this role in further detail.
Sebastian Spaniol
s.spaniol'@'realstaffing.com