QA Qualification Engineer — GMP System Lifecycle Lead (Hybrid)

Panda International; Beerse; Hybride; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Beerse, Belgium-based global pharmaceutical leader seeks a Medior to Senior QA Qualification Engineer to support process equipment qualification and lifecycle management in a GMP environment. The role spans commercial, clinical and CAR-T operations, with a strong emphasis on risk-based qualification and compliance across the site.

Hybrid work arrangement (3 days onsite, 2 days home), start ASAP, 12-month contract with potential extension; 80-100% FTE depending on project needs.

Qualifications

• 5+ years of QA experience in a regulated pharma environment.
• Experience with qualification activities and risk-based methodologies.
• University/Bachelor's degree or equivalent.

Responsabilités

• Review risk assessments to ensure a risk-based approach aligns with quality principles.
• Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, tests, reports).
• Review and approve procedures related to qualification, calibration, maintenance and lifecycle management.
• Investigate deviations, implement CAPAs and ensure effective closure.
• Stay current on international regulations and guidance for system qualification.
• Support regulatory inspections, customer audits and internal assessments.
• Collaborate with stakeholders across process/lab equipment, utilities, sterile areas, testing and change controls.

Connaissances

QA experience

Regulatory compliance

Risk-based thinking

Cross-functional collaboration

Formation

Bachelor's degree

Description du poste

Beerse, Belgium-based global pharmaceutical leader seeks a Medior to Senior QA Qualification Engineer to support process equipment qualification and lifecycle management in a GMP environment. The role spans commercial, clinical and CAR-T operations, with a strong emphasis on risk-based qualification and compliance across the site.

Hybrid work arrangement (3 days onsite, 2 days home), start ASAP, 12-month contract with potential extension; 80-100% FTE depending on project needs.