Beschreibung
French speaking Architect (with CSV/GMP skills) is required for a 6 month contract assignment located in Switzerland
Project: Integrating a team in charge of implementation and data integrity compliance of validated Computerized Systems in the framework of GxP-regulated laboratory activities related to biopharmaceutical products (Clinical trials and/or for commercial use).
The ideal candidate for the role should have:
- Min 5 years of experience in IT technologies
- Min 3 years of experience in a GLP/GMP environment (evidence of GxP training is required)
- Fluent French (written and spoken) is a must. A good level in English is a definite plus
Tasks will include:
- Reviewing URS
- Defining Architecture design specification
- Developing User and Functional Requirements documentation
- Implementing the software solution
- Participating in Risk Assessments
- Reviewing vendor and internal IQ-OQ documentation
- Hand-over to support team
- Managing change control documentation for validated systems, including related testing