Validation Consultant - CSV & IT Quality

Our client, a global biotechnology organization, is seeking a professional to support their digital technology compliance team with computer systems lifecycle management and IT quality processes. The role involves ensuring the integrity and compliance of computerized systems within a highly regulated environment.

• Write, review, and approve validation and qualification deliverables within the electronic document management system.
• Ensure compliance with internal SOPs and external regulations including GxP, SOx, and Data Privacy.
• Deliver project validation and qualification requirements consistently and within specified timelines.
• Assist in the development and review of validation and qualification SOPs and templates.
• Resolve computerized system validation compliance issues and manage quality events such as CAPAs, deviations, and change controls.
• Maintain effective and open communication with stakeholders across quality, data engineering, and security domains.

• You have a Master or Bachelor in Computer Science, Life Sciences, or Engineering.
• You bring 8+ years of experience as a Validation Consultant or Quality Manager for computer systems within the pharmaceutical or biotech industry.
• You possess expert knowledge of regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, GAMP5, and CSA.
• You have extensive experience with the qualification of infrastructure and cloud platforms such as Azure, AWS, or OCI.
• You bring hands-on experience with cloud data warehouses like Snowflake or Databricks, data visualization tools such as Tableau or Power BI, and AI governance for LLMs.
• You’re a proactive communicator with a critical mind, high attention to detail, and a pragmatic approach to problem-solving.
• You are fluent in English.

Nice to Haves

• Experience with Veeva, ERP, QMS, ServiceNow, or Jira.
• Proficiency with the latest versions of the 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.
• Werk in een dynamische en ondersteunende omgeving waar je echt het verschil kunt maken.
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• Kies een flexibele mobiliteitsoplossing, van een bedrijfswagen tot een openbaar vervoer abonnement.
• Bouw je netwerk uit en beleef onvergetelijke momenten tijdens exclusieve events en afterworks.
• 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.