Brussels, Brussels Region, Belgium
Seasoned Quality Assurance Specialist with over a decade of experience in GMP-regulated pharmaceutical environments. Proven expertise in APQR, API release, inspection readiness, trending analytics, and cross-functional leadership. Certified Six Sigma Green Belt with a strong foundation in clinical imaging, medical devices, and biotech innovation. Adept at navigating complex regulatory frameworks and driving quality improvements that foster compliance and operational excellence.
Lead the Annual Product Quality Review process through collaboration with production, QC, and support teams. Analyze and communicate quality metrics, ensuring timely approval and inspection readiness. Train teams on APQR best practices and manage escalation and resolution of quality issues.
Managed release of vaccine APIs and resolved technical challenges with cross-functional teams. Performed trend analyses on deviations, complaints, and CPVs, improving QA operations. Coordinated internal audits, self-inspections, and compliance programs across the MPU.
Collaborated with CMOs to produce and validate APQRs and supplier quality reports. Oversaw deviation, change controls and CAPA management tied to external partners. Supported audits, technical agreements, and QA oversight of outsourced activities.
Supported risk management and QA processes for drug and device development. Reviewed and approved DHFs and FMEAs; trained teams on QMS protocols. Led preparations for internal and external audits.
Directed central reader teams for clinical imaging QA and software training. Project management of imaging clinical trials Managed audit preparations and clinical deviations within imaging studies.