Site Conformance Expert - GMP & QA in Life Sciences

Capgemini Engineering; Diegem; Sur place; EUR 45 000 - 55 000; Plein temps

Résumé du poste

Capgemini Engineering is seeking a Site Conformance Expert within our Quality Assurance team. You will ensure regulatory compliance across Manufacturing Performance Units and Quality Control, acting as the vital link between operations and regulatory affairs.

With a Master's in Life Sciences and at least 3 years in QA, you will oversee GMP and regulatory documentation, including eCTD, and collaborate across functions to strengthen quality systems globally.

Qualifications

• Master's degree in a life sciences field with ≥3 years QA experience in pharma.
• Strong knowledge of GMP, quality systems and regulatory requirements.
• Fluent in English and French with excellent cross-functional communication.
• Proactive team player able to manage multiple priorities in a regulated environment.

Responsabilités

• Ensure regulatory dossiers and health authority responses across MPU and QC.
• Provide regulatory oversight to align with evolving requirements.
• Analyze compliance gaps and develop mitigation for supply issues or recalls.
• Collaborate with cross-functional teams to maintain global quality systems.

Connaissances

GMP knowledge

Regulatory compliance

eCTD knowledge

English and French

Formation

Master's in Life Sciences

Outils

eCTD format

Description du poste

Capgemini Engineering is seeking a Site Conformance Expert within our Quality Assurance team. You will ensure regulatory compliance across Manufacturing Performance Units and Quality Control, acting as the vital link between operations and regulatory affairs.

With a Master's in Life Sciences and at least 3 years in QA, you will oversee GMP and regulatory documentation, including eCTD, and collaborate across functions to strengthen quality systems globally.