Senior QA Engineer - GMP/Regulatory Compliance Lead

Vulcain Engineering Group | Belgium; Luik; Presencial; EUR 70.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company car

Fuel card

Meal vouchers

Insurances

Eco cheques

Sectorial bonus

Descripción de la vacante

Vulcain Engineering Belgium in Liège is seeking a Senior QA Engineer to ensure products meet customer and regulatory requirements for products and manufacturing processes.

You will review manufacturing and testing against quality standards, manage quality systems, and ensure GMP-compliant contractor quality. The role demands GMP experience, regulatory insight, and fluency in French with professional English.

Formación

• Master's degree in life sciences, biotechnology, pharmaceuticals, or any relevant engineering field.
• At least 8 years of experience in QA/regulatory context.
• Experience in GMP environments and regulatory interpretation.

Responsabilidades

• Review manufacturing/testing against quality standards and marketing authorizations.
• Manage quality systems: change control, deviations, investigations.
• Ensure contractor quality standards meet GMP requirements.
• Review batch abstracts for product release per specifications.
• Monitor contractor compliance via GxP documentation and audits.
• Distribute contractor documentation for Regulatory, Validation, and SME review.
• Interact with multifunctional internal and external project teams for compliance.
• Respond to technical and quality issues and manage conflicts.
• Understand regulations related to medicinal product manufacture (biologics).
• Manage notification flows in quality systems between partners.
• Monitor contractor performance to establish KPIs and report adverse trends.

Conocimientos

QA Management

Regulatory knowledge

GxP compliance

Quality systems

Educación

Master's degree in life sciences or related field

Descripción del empleo

Vulcain Engineering Belgium in Liège is seeking a Senior QA Engineer to ensure products meet customer and regulatory requirements for products and manufacturing processes.

You will review manufacturing and testing against quality standards, manage quality systems, and ensure GMP-compliant contractor quality. The role demands GMP experience, regulatory insight, and fluency in French with professional English.