QA Qualification Engineer

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

Our client, a global leader in the pharmaceutical industry, is looking for a QA Qualification Engineer to join their Quality team in Beerse. This is a great opportunity to work across commercial, clinical and CAR-T operations, supporting equipment qualification and lifecycle management in a highly regulated GMP environment.

• Start: ASAP
• Duration: until 12 months
• Onsite/offsite: Hybrid - 3 days onsite, 2 days home (may flex more onsite depending on project needs)
• FTE: 100% preferred (80% considered for strong candidates)

About the role

As QA Qualification Engineer, you'll provide QA support for process equipment qualification activities across the full system lifecycle - from risk assessment through to remediation of legacy systems. You'll work closely with cross-functional teams to keep qualification and compliance on track.

Key responsibilities

• Review risk assessments to ensure the right risk-based approach is applied, in line with current quality principles
• Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, qualification reports)
• Review and approve procedures related to qualification, calibration, maintenance and system lifecycle management
• Assess, investigate and resolve deviations related to systems, ensuring effective CAPAs
• Stay current on international regulations and industry guidance for system qualification
• Support regulatory inspections, customer audits and internal compliance assessments
• Collaborate with stakeholders across process/lab equipment, site utilities, sterile areas, filter testing and change controls

What we're looking for

• Medior to senior QA professional (5+ years minimum; 8-10+ years for senior profiles) with experience in a regulated pharmaceutical environment
• Demonstrated experience in qualification activities and risk-based methodologies
• University/Bachelor's degree or equivalent
• Strong quality and compliance mindset, with the ability to constructively challenge while maintaining productive stakeholder relationships
• Excellent communication skills; comfortable discussing difficult topics and working closely with business partners
• Fluent in English and Dutch (spoken and written)
• Based in Belgium
• Flexibility required during summer and Christmas periods