Senior QA Engineer - GMP & Regulatory Lead

Vulcain Engineering Group | Belgium; Luik; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Company car

Fuel card

Representation fees

Insurances

Meal vouchers

Eco cheques

Sectorial bonus

Résumé du poste

Vulcain Engineering Belgium is seeking a Senior QA Engineer to join the Liège team. The role ensures products meet customer and regulatory requirements related to products and manufacturing processes.

The position requires a Master’s degree in life sciences or related field, 8+ years of experience, fluency in French and professional English, and solid GMP familiarity. The company highlights a competitive package and opportunities within a specialized energy sector.

Qualifications

• Master’s degree in life sciences, biotechnology, pharmaceuticals, or any relevant engineering field.
• Minimum 8 years of experience.
• Good understanding of current regulatory requirements and expectations in product development context.
• Fluent in French and professional level of English.

Responsabilités

• Review all aspects of product manufacturing and testing against quality standards and marketing authorizations.
• Manage quality systems, e.g. change control, deviations, and product investigations.
• Review contractor quality standards and GMP compliance for processing materials into finished products.
• Review batch abstracts to release products per approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site audits.
• Interact with multi-functional internal and external teams to ensure compliance.
• Respond to technical and quality issues and handle schedule/process-related conflicts.
• Demonstrate understanding of regulations related to manufacture of medicinal products (biologics).
• Manage notification flows in quality systems between internal and external partners.
• Monitor contractor performance to establish KPIs and report adverse trends.

Connaissances

Quality assurance

GxP compliance

GMP environment

Regulatory understanding

English proficiency

French language

Formation

Master’s degree

Life sciences / engineering

Description du poste

Vulcain Engineering Belgium is seeking a Senior QA Engineer to join the Liège team. The role ensures products meet customer and regulatory requirements related to products and manufacturing processes.

The position requires a Master’s degree in life sciences or related field, 8+ years of experience, fluency in French and professional English, and solid GMP familiarity. The company highlights a competitive package and opportunities within a specialized energy sector.