QA Qualification Engineer — Beerse, Belgium (Hybrid)
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.
Contract details
- Start: ASAP
- Duration: 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)
- 2 positions available
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
- BYOD required - candidate must bring own device, or Panda provides IT equipment (WWID access to client systems provided separately)