GMP Quality Systems Specialist

Real; Breda; Vor Ort; EUR 55.000 - 90.000; Vollzeit

Zusammenfassung

Real is seeking a QA Systems & Compliance Expert for a leading global healthcare organization focused on radioligand therapies and GMP manufacturing in Breda. The role maintains and improves the Quality Management System to ensure regulatory compliance and site readiness.

You will collaborate across operations, quality, and suppliers to drive CAPA, data integrity, change control, and continuous quality improvement, supporting inspections and governance.

Qualifikationen

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field.
• Experience in Quality Assurance within GMP-regulated pharma/biotech environments.
• Strong knowledge of Quality Systems and GMP regulations.

Aufgaben

• Maintain and continuously improve the Quality Management System (QMS).
• Ensure GMP, regulatory, and data integrity compliance.
• Manage quality documentation lifecycle (review, approval, archiving).
• Perform gap assessments and implement global quality procedures.
• Coordinate CAPA activities and effectiveness checks.
• Support deviation, incident, and quality event management.
• Review and approve routine and complex change controls.
• Plan and execute Product Quality Reviews (PQR/APQR).
• Monitor and report quality KPIs and KQIs.
• Maintain inspection readiness and support regulatory inspections and audits.
• Manage supplier qualification activities, audits, and quality agreements.
• Support incoming material quality oversight and supplier compliance.
• Support complaint management and tracking activities.
• Drive data integrity and eCompliance initiatives.
• Support quality governance meetings and self-inspections.
• Participate in global quality projects and continuous improvement initiatives.

Kenntnisse

Quality Assurance

GMP regulations

CAPA

Deviations

Change control

Audit management

Supplier quality management

Data integrity

Analytical skills

Stakeholder management

Ausbildung

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field

Jobbeschreibung

Real is seeking a QA Systems & Compliance Expert for a leading global healthcare organization focused on radioligand therapies and GMP manufacturing in Breda. The role maintains and improves the Quality Management System to ensure regulatory compliance and site readiness.

You will collaborate across operations, quality, and suppliers to drive CAPA, data integrity, change control, and continuous quality improvement, supporting inspections and governance.