Quality Assurance Engineer — cGxP/GMP

Vulcain Engineering Group | Belgium; Luik; Sur place; EUR 44 000 - 55 000; Plein temps

Avantages offerts par ce poste

Company car

Fuel card

Meal vouchers

Insurances

Eco cheques

Sectorial bonus

Résumé du poste

Vulcain Engineering Belgium is seeking a QA Engineer to join its consulting team. The role focuses on ensuring product manufacturing/testing meet quality standards and regulatory requirements, while managing quality systems and contractor compliance.

The ideal candidate has a 3–5 year background in a cGxP or regulated environment, with 1 year in quality, and is fluent in English and French. A competitive package is offered, including social benefits and opportunities for growth.

Qualifications

• Bachelor’s or Master’s degree with 3–5 years in a cGxP or regulated environment, including 1 year in a quality role.
• Excellent communication and organizational skills.
• Attention to detail and right-first-time quality.
• Fluency in English and French is mandatory for the position.

Responsabilités

• Review manufacturing/testing against quality standards and marketing authorizations.
• Manage quality systems: change control, deviations, and product investigations.
• Modify, review, and ensure contractor quality standards meet GMP requirements.
• Review batch abstracts to release products per approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site audits/visits.
• Distribute contractor documentation for Regulatory, Validation, and SME review.
• Interact with cross-functional internal and external project teams to ensure compliance.
• Respond to technical and quality issues and resolve schedule/process conflicts.
• Understand applicable 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

GxP compliance

Quality assurance

Documentation

English & French

Formation

Bachelor’s or Master’s degree in a relevant field

Description du poste

Vulcain Engineering Belgium is seeking a QA Engineer to join its consulting team. The role focuses on ensuring product manufacturing/testing meet quality standards and regulatory requirements, while managing quality systems and contractor compliance.

The ideal candidate has a 3–5 year background in a cGxP or regulated environment, with 1 year in quality, and is fluent in English and French. A competitive package is offered, including social benefits and opportunities for growth.