6h ago

Quality Assurance Engineer - CAR-T

Ghent, Belgium
full-timemidPharmaceuticals / Biotech

Requirements

  • Bachelor's degree in a relevant field (e.g., engineering, life sciences)
  • Experience in quality assurance within pharmaceutical or biotech industry
  • Knowledge of GMP, regulations, and industry practices
  • Experience with qualification of facilities, utilities, and equipment
  • Strong communication and investigation skills

Responsibilities

  • Review and approve qualification/requalification activities for facilities, utilities, and process equipment
  • Ensure critical system aspects are identified, qualified, and controlled; investigate deviations
  • Approve change controls and ensure evaluation of quality/compliance deviations
  • Manage compliance status by reviewing calibration, maintenance, and data integrity records
  • Participate in regulatory inspections and approve qualification documents including discrepancies and CAPAs
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