QA Engineer – Quality Systems & Compliance

About the role

Vulcain Engineering Belgium is seeking a QA Engineer to join its consulting team. The role focuses on ensuring that product manufacturing and testing meet established quality standards and regulatory authorisations, while supporting contractor compliance and quality system management.

Key responsibilities

• Review product manufacturing and testing against quality standards and marketing authorisations.
• Manage quality systems, including change control, deviations, and product investigations.
• Modify and review contractor quality standards and protocols to meet GMP requirements.
• Release products by reviewing batch abstracts in line with approved specifications.
• Monitor contractor compliance through GxP documentation review and on‑site audits.
• Distribute contractor documentation for regulatory, validation, and subject‑matter‑expert review.
• Interact with internal and external project teams to ensure compliance and resolve technical or schedule conflicts.
• Track contractor performance, establish KPIs, and report adverse trends.

Required profile

• Bachelor’s or Master’s degree.
• 3–5 years of experience in a cGxP or other regulated environment, including at least 1 year in a quality role.
• Excellent communication and organisational skills.
• Strong attention to detail and commitment to high‑quality work.
• Fluency in English and French.

Required skills

• cGxP knowledge.
• Good Manufacturing Practice (GMP) understanding.
• GxP documentation handling.
• Change control and deviation management.
• Product investigation processes.
• Batch release procedures.
• KPI monitoring and reporting.
• Regulatory compliance for medicinal products (biologics).

What we offer

• Competitive gross salary ranging from €44,000 to €55,000 paid over 13.92 months.
• Company car with fuel card.
• Representation fees, insurances, meal vouchers, and eco‑cheques.
• Opportunity to work on challenging projects within the life‑sciences sector.