IT Service Management Lead
il y a 4 jours
Global Lead – IT Computer System Validation (CSV)
Department: IT
Reports to: Enterprise IT Architect.
Are you a seasoned expert in Computer System Validation (CSV) with a passion for quality, compliance, and innovation in the pharmaceutical industry? At Prothya Biosolutions, we’re looking for a Global Lead IT CSV to drive validation excellence across our computerized systems and ensure they meet the highest regulatory standards.
🎯 As our Global Lead for IT CSV, you’ll lead validation efforts across the organization, ensuring systems are fit for purpose, compliant, and aligned with GxP requirements. You’ll collaborate with cross-functional teams, mentor IT professionals, and shape validation strategies that support operational efficiency and regulatory compliance.
🛠️ Lead IQ/OQ/PQ activities, coordinate testing, document results, and manage deviations in line with internal CSV procedures.
Train & Mentor
Educate IT teams on CSV processes and regulatory expectations. Manage Documentation
Work closely with IT, Automation, Production, QA, QC, Medical Affairs, and Supply Chain to align validation strategies and decisions.
👤 Minimum 5 years of experience in CSV, ideally within the pharmaceutical sector.
Strong knowledge of GAMP5, 21 CFR Part 11, EU Annex 11 , and pharmaceutical quality systems.
Conceptual understanding of IT and IT-OT architecture, including networks, applications, and automation systems.
Experience with Document Management Systems and Quality Management Systems .
Fluent in English ; Dutch is a plus.
Able to handle time pressure and influence quality outcomes across systems.
Are you looking for a position at a flexible and fast-growing company with an exciting history? Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).
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