Auditor is a highly experienced Independent Pharma Consultant and Quality Auditor with over 35 years of expertise in the pharmaceutical sector. Holding an IRCA Registered QMS Lead Auditor certification from TUV Nord (Germany), they have been engaged in various consultancy projects since 2019. Their roles included EDQM audit remediation, PMDA & EDQM re-inspection support, GMP trainings, and regulatory assessment audits for national and international firms. Prior positions at Alembic Pharmaceuticals Ltd., Sun Pharmaceuticals Ltd., and Unichem Laboratories Ltd. involved overseeing quality assurance, control, regulatory inspections, and compliance activities. Their career highlights include implementing quality management systems, handling regulatory audits, and leading quality improvement initiatives, demonstrating a steadfast commitment to quality excellence and regulatory compliance in the pharmaceutical industry.