수평: Associate
직업 종류: Part-time
작업 내용
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.
마감 시간: 28-12-2025
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