We are a Belgian engineering consulting firm that assists SMEs and large industrial organizations in bringing their innovation and R&D initiatives to life.
Job Description :
- Responsible for the validation according to the current GMP guidelines for an automated control system : - Writing commissioning and qualification tests based on user requirements and functional specifications - Executing tests in an accurate and GMP manner - Performing risk assessments - Point of contact for validation topics, both internal and external - Work in a project team, follow up on schedules and milestones
Profile / Requirements :
Experience with GAMP5, 21CFR part 11 and computer system validation - Affinity with computerized systems, such as PLC, SCADA,… - Fluent in Dutch and English - Good analytical & communication skills - Willingness to travel (sporadically) - Bachelor or higher technical degree - At least 2 years relevant (pharmaceutical GMP environment) experience - Knowledge of office applications : Word, Excel, Outlook