- Languages English
- Experience Senior (+5 years)
Our client, an important key player in the MedTech industry, is now looking for a Validation Manager
You will lead validation activities and project teams to ensure compliance of the products.
Among your main missions:
– Planning and allocation of resources for projects.
– Lead project teams and more specifically manage the validation team (4 people)
– Writing of requirements and design-specification (DQ).
– Lead risk assessments of designed processes within multidisciplinary teams.
– Writing of test scripts to verify deliverables against specification with focus on patient safety, product quality and data integrity (IQ/OQ/PQ).
– Ensure compliance with EU-GMP (Good Manufacturing Practice) and FDA requirements.
– Support of internal and external audits.
- Bachelor or Master degree (technical, life science or related)
- Relevant work experience preferably in Medtech industry
- Team management
- Working knowledge of validation of products/equipment/ processes, computer system validation, risk management
- Knowledge of relevant Medical Device regulations
- English and French fluent, German is a must
- You have excellent communication skills, and contribute to team-based decisions.