Process Validation Specialist

Il y a 2 jours

Zwijnaarde, Oost-Vlaanderen, Belgique Pauwels Consulting Temps plein 75 000 € - 110 000 €/an

Pauwels Consulting is seeking a specialist to support base business validation activities and strategic projects in a cell and gene therapy environment. You will design and implement process validation strategies to ensure cGMP readiness and process robustness.

You will draft and maintain batch records, Validation Master Plans, and related documentation, oversee PPQ, CCIT, aseptic simulations, and hold time studies, and act as SME during FDA/EMA audits.