Life Sciences Quality Engineer: GMP & Regulatory Compliance

Capgemini Engineering; Diegem; Sur place; EUR 52 000 - 75 000; Plein temps

Avantages offerts par ce poste

Free training assets

Mentoring programs

Global leader

Résumé du poste

Capgemini Engineering is seeking a Quality Engineer in Life Sciences to uphold and enhance quality systems, ensuring regulatory compliance across pharma and biotech environments. You will support continuous improvement, audits, and documentation readiness for inspections.

We require a minimum of 2 years in QA/quality engineering, a degree in Engineering/Life Sciences/Pharmacy, and proficiency in French or Dutch plus English.

Qualifications

• Minimum 2 years in quality assurance or quality engineering in Life Sciences.
• Solid knowledge of GMP and major regulatory frameworks.
• Ability to apply quality standards in projects.

Responsabilités

• Maintain and improve quality management systems (QMS) per GMP and ISO 13485.
• Lead QA/QC activities: batch reviews, product release, CAPA, deviation handling.
• Conduct internal/external audits and drive corrective actions.
• Collaborate with manufacturing, validation, regulatory affairs and supply chain.
• Prepare and review SOPs, risk assessments, audit reports and metrics.

Connaissances

GMP regulations

Quality systems

CAPA & root cause

Regulatory compliance

Cross-functional collaboration

Formation

Engineering degree

Life Sciences degree

Pharmacy degree

Description du poste

Capgemini Engineering is seeking a Quality Engineer in Life Sciences to uphold and enhance quality systems, ensuring regulatory compliance across pharma and biotech environments. You will support continuous improvement, audits, and documentation readiness for inspections.

We require a minimum of 2 years in QA/quality engineering, a degree in Engineering/Life Sciences/Pharmacy, and proficiency in French or Dutch plus English.