Validation Consultant - CSV & eCompliance

Our client, a leading life sciences organization, is seeking a Validation Consultant to support their digital technology compliance team. The project focuses on managing the lifecycle of computer systems and supporting IT quality processes within research and development environments.

• Establish quality frameworks to maintain computerized systems in compliance with internal and external regulations such as data privacy and cybersecurity.
• Ensure project deliverables are complete, consistent, and delivered according to project timelines.
• Support the creation and review of validation and qualification SOPs and templates.
• Resolve computerized system validation and qualification compliance issues.
• Manage quality events including change controls, deviations, and CAPA.
• Communicate effectively with multidisciplinary stakeholders across research, development, and security departments.

• You have a Bachelor or Master in Computer Science, Life Sciences, or Engineering.
• You bring 5+ years of experience as a validation consultant or quality manager for computer systems within GLP and GCP regulated environments.
• You possess deep knowledge of FDA 21 CFR Part 11, EU Annex 11, and ICH Guidelines regarding data management.
• You have expertise in Data Integrity controls and risk assessments using GAMP 5 or CSA frameworks.
• You bring experience managing early drug discovery, clinical, and pre-clinical biomarker research data within cloud-based R&D platforms.
• You have knowledge of AI governance frameworks, including Generative AI and LLMs.
• You're an autonomous professional with a critical mind, high attention to detail, and a pragmatic approach.
• You are fluent in English.

Nice to Haves

• Experience with software systems such as Veeva, QMS, ServiceNow, or Jira.
• Proficiency with the latest MS Office software package.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
• Versnel je carrière met een helder groeipad, coaching en mentoring ter ondersteuning.
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• Kies een flexibele mobiliteitsoplossing, van een bedrijfswagen tot een openbaar vervoer abonnement.
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• Breid je vaardigheden uit met externe opleidingen en onze in-house Pauwels Academy.
• Werk aan uitdagende projecten met toonaangevende klanten in Life Sciences, Engineering & Digital.
• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.