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Quality assurance analyst

Beerse
Planet Pharma
Publiée le 3 juillet
Description de l'offre

Quality Assurance Analyst (CSV Validation – Part-Time, Hybrid in Beerse)Location: Beerse (Hybrid – 1x/week initially, then 1x every 2–3 weeks)Contract type: 0.5 FTE | 6-Month ContractWe are seeking a Quality Assurance Analyst with expertise in Computer System Validation (CSV) to support one of our trusted partner organizations—a global leader in the pharmaceutical and biomedicine sector. This is a hybrid role based in Beerse, offering flexible on-site requirements and the opportunity to contribute to high-impact, regulated projects within a cutting-edge life sciences environment.Responsibilities:Validation Planning: Design and execute validation strategies aligned with industry regulations and internal SOPs.Documentation: Prepare and maintain validation documentation (plans, protocols, reports) in compliance with SDLC and related procedures.Risk Assessment: Identify validation-related risks and propose mitigation strategies.Testing: Lead and participate in CSV testing phases (IQ, OQ, PQ).Cross-Functional Collaboration: Partner with IT, QA, and Regulatory Affairs to ensure alignment and timely delivery of validation activities.Regulatory Compliance: Ensure full adherence to FDA, ISO, and internal validation standards.Training & Guidance: Support team members in applying CSV best practices and ensuring procedural compliance.Qualifications:Bachelor’s degree or higher in sciences (e.g., Chemistry, Biology, Pharmacy, IT, Engineering).3–5 years of hands-on experience in CSV within regulated environments.Strong knowledge of SDLC and its role in validation processes.Experience in pharmaceutical or healthcare industries is preferred.Exceptional documentation, analytical, and problem-solving skills.Fluency in English and Dutch (spoken and written) is required.If you're a validation professional seeking a flexible, part-time engagement with a high-profile pharmaceutical environment, we'd love to hear from you.Apply now to take the next step in your validation career.

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