The Auditor is a seasoned professional with 18 years of global experience in Quality and Clinical domains, specializing in Drug and Device Quality. They hold certifications such as ASQ Lead Auditor and ISO 13485 IRCA Lead Auditor, excelling in audits, compliance, and project execution. With expertise in FDA-PAI, EU GMP, MDD-MDR, and ISO readiness, they have audited Medical Device sites and labs worldwide, managing projects in pharmaceutical and biotech sectors. Their key skills include effective communication, project management, and a quality-focused approach.