Description
One of our clients, an international company in the pharmaceutical industry currently requires a Computerized System Validation Engineer/GMP/GCP
Activities:
- Working within the UCB IT Compliance Solutions team as external to deliver GxP validated Computerized Systems/Information Technologies
- Support IT Computerized System Validation (CSV) activities in area of GMP, GCP and/or medical devices
- Execute CSV project activities
- Support current IT Compliance team with operational activities like review of VPL & VSR, execute periodic review
Qualifications:
- Knowledge of pharma regulatory requirements
- Computerized system validation experience in Pharma environment
- CSV experience in one of following domains:
- GMP
- GCP
- Medical Devices
- Understanding of risk related to use of personal health data is a plus
- Very good knowledge of MS Office suite
- Soft skills: Logic, proactive & analytical behavior
- Attention for stakeholder identification & good communication skills
- Fluent English; French, Dutch or German a plus
Tags: CSV, Computerized System Validation Engineer, pharmaceutical