Beschreibung
For our client we are looking for an experienced IT Architect with knowledge of CSV/GMP.
YOUR CV WILL ONLY BE TAKEN INTO CONSIDERATION IF YOU ARE FRENCH SPEAKING.
Our client is currently looking for a profile to integrate 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 candidate will be the IT representative ensuring:
- Implementation of GxP systems supporting QC and manufacturing activities
- Assessment and mitigation of all system Data integrity vulnerability
- Development of standard infrastructure tools to support data integrity compliancy
Your responsibilities:
- 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
Your qualifications and experience:
- Min 5 years of experience in IT technologies
- Min 3 years of experience in a GLP/GMP environment (evidence of GxP training is required)
Practical knowledge in at least one of the following is a plus:
- Computerized software validation
- Writing of quality procedures (SOPs, Work Instructions)
Start: ASAP
Duration: 6 months
Location: Switzerland, the French speaking part.
Work load: 100%
Working language: Fluent French (written and spoken) is a must. A good level in English is a definite plus