BE - QA Qualification Engineer
Panda International
BE - QA Qualification Engineer
Samenvatting
Wat krijg je?
Wat ga je doen?
- Review and approve risk assessments
- Approve various technical qualification deliverables
- Approve system lifecycle management procedures
- Investigate and resolve system deviations
- Monitor international system qualification regulations
Wat verwachten wij?
- 5 tot 10 jaar QA ervaring in farma
- Ervaring met kwalificatieactiviteiten en risicogebaseerde methodologieën
- Ervaring met het goedkeuren van kwalificatierapporten en protocollen
- Woonachtig in België
Volledige vacaturetekst
Als QA Qualification Engineer bij een wereldwijde farmaceutische marktleider in Beerse werk je mee aan cruciale commerciële, klinische en CAR-T operaties. Je bewaakt de kwaliteit van apparatuur over de gehele levenscyclus binnen een hoogwaardige GMP-omgeving. Dankzij de hybride werkregeling geniet je van een optimale balans tussen thuiswerk en innovatie op de site. Zet jouw expertise in voor grensverleggende projecten en til de kwaliteitsstandaard naar een hoger niveau. Ontdek of deze uitdaging bij jou past!
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)
Over de werkgever
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