Hybrid QA Qualification Engineer — Beerse, Belgium

Panda International

Beerse

Hybride

EUR 60 000 - 90 000

Plein temps

Il y a 2 jours
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Résumé du poste

Panda International in Beerse, Belgium, is seeking a QA Qualification Engineer to join its Quality team on a hybrid basis. You will support equipment qualification activities across the full lifecycle under GMP, collaborating with cross-functional teams to ensure compliance and timely delivery.

The role requires 5+ years in QA within a regulated pharmaceutical environment, with risk-based qualification methods and strong communication skills in English and Dutch.

Qualifications

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

Responsabilités

  • Review risk assessments to ensure risk-based approaches align with quality principles.
  • Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, 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.

Connaissances

QA experience
Regulatory compliance
Documentation review
Cross-functional collaboration

Formation

Bachelor's degree

Description du poste

Panda International in Beerse, Belgium, is seeking a QA Qualification Engineer to join its Quality team on a hybrid basis. You will support equipment qualification activities across the full lifecycle under GMP, collaborating with cross-functional teams to ensure compliance and timely delivery.

The role requires 5+ years in QA within a regulated pharmaceutical environment, with risk-based qualification methods and strong communication skills in English and Dutch.

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