CRQA Senior Pharmacovigilance Auditor is a Quality Management professional with a career spanning about 25 years in Pharma, Healthcare and Biotech industry. She has expertise in Good Clinical Practice, Good Pharmacovigilance Practice, Good Laboratory Practice, CFR part 11 compliance and Good Manufacturing Practice auditing. She has worked with small and large companies and audited many pharmaceutical companies and Contract Research Organizations/Vendors globally covering pre and post marketing Quality assurance programs in different therapeutic areas especially IND directed studies. She has managed and facilitated due diligences/ out-licensing of NCEs/ NCE co-development programs and has experience in handling MHRA/FDA/DCGI inspections and readiness for inspections in GXP area. She holds a Master’s degree in Pharmacology from Hamdard college of Pharmacy, New Delhi, India.