QA Engineer

Champion GMP excellence as the key Quality partner connecting alliance operations to compliant, world‑class pharmaceutical delivery.

R&D Partners is seeking a QA Engineer to act as the primary point of contact for quality-related activities with alliance partners at a leading pharmaceutical company. This role involves ensuring GMP compliance, managing quality systems, and supporting the release team in Geel.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Serve as the day-to-day liaison with alliance partners for quality-related activities.
• Ensure GMP compliance of company products manufactured and/or tested at partner facilities.
• Manage quality systems, including change control, deviations, and product investigations.
• Contribute to project milestones and support the release team in Geel.
• Review and approve DS/FDS batch documentation for cGMP compliance and regulatory conformance.
• Manage change control intake, perform impact assessments, and coordinate partner notifications.
• Oversee deviation management, including intake, assessment, escalation, and partner notifications.
• Generate and review analytical batch abstracts and quarterly change reports.
• Provide CMC change assessments for commercial release decisions and supplementary releases.
• Conduct preliminary regulatory assessments, ensure GRA alignment, and perform CTD reviews.
• Lead QA workstreams for tech transfers and provide quality oversight for alliance partner interfaces.
• Support and prepare for audits and inspections, including documentation and response coordination.

Key Skills and Requirements:

Education:

• Master’s degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, or equivalent.

Experience:

• 3-5 years of experience in a cGxP or other regulated environment.
• Minimum of 3 years in a Quality role.

Competencies and Skills:

• Full professional proficiency in Dutch and English.
• Strong organizational skills and attention to detail.
• Knowledge of GMP guidelines and pharmaceutical quality systems.
• Ability to work independently, prioritize tasks, and maintain a proactive, solution-oriented attitude.

For more information, please contact Mandi Cakwe.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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