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Quality Assurance Specialist

Hydrogen GroupAntwerp, Flemish Region, Belgium

8 dagen geleden

Functieomschrijving

Shape the Future of Pharma Compliance – Quality Assurance Analyst (CSV)

6-Month Contract | Part-Time (0.5 FTE) | Hybrid – Antwerp, Belgium

Are you a detail-driven validation professional ready to support cutting-edge pharmaceutical innovations? We’re partnering with a global leader in biomedicines to find a Quality Assurance Analyst with a strong background in Computer System Validation (CSV) .

This flexible, part-time opportunity offers the best of both worlds : the impact and prestige of working with a leading pharma company, and the work-life balance of a hybrid model—on-site just once every 1–3 weeks in Antwerp.

Why This Role?

Contribute to high-impact projects at the heart of pharmaceutical innovation.
Play a key role in ensuring compliance and patient safety through robust validation processes.
Enjoy hybrid flexibility with minimal on-site requirements and a collaborative, high-performing team.
Be a trusted advisor, trainer, and cross-functional partner—shaping how validation is executed and documented.

What You’ll Do

Develop and execute robust CSV validation strategies aligned with regulatory and company standards.

Lead validation documentation efforts—plans, protocols, and reports—under SDLC-compliant SOPs .

Conduct risk assessments and define mitigation strategies to ensure compliance at every step.

Participate in and lead testing activities (IQ / OQ / PQ) to support system readiness and integrity.

Collaborate with IT, QA, and regulatory affairs to meet project timelines and compliance goals .

Provide training and guidance on validation best practices and documentation quality.

What We’re Looking For

Bachelor’s degree or higher in a relevant field (sciences, IT, engineering, etc.).

3–5 years of hands-on CSV experience in a regulated pharma or healthcare environment .

Solid grasp of the Software Development Life Cycle (SDLC) and its application in validation.

Fluent communication in English and Dutch , both written and spoken.

Strong analytical and documentation skills, with a proactive, quality-first mindset.

If you’re passionate about quality, compliance, and making a meaningful contribution in the pharmaceutical space— this role is built for you . Apply directly or reach out to : madelinejarra@hydrogengroup.com and be part of something that truly matters.

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Quality Assurance Specialist • Antwerp, Flemish Region, Belgium