Description
Mission Description:Activities are:
Working within the 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
Hours per week:
8 hours / days per week; Time indicatively from 09.00 to 18.00
5 days/week
Duration of the assignment:
6 months Possible extension
Start date (est.):
Start Date: Jan 2016 - End Date: Jun 2016 (extension possible)