Quality Assurance Specialist

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 Contract

We 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.