QA expert with 13 Years of experience, Expertise in QA Programs, CAPA, RCA. Conducted more than 300 GCP audits. Successfully faced regulatory inspections (and led inspection readiness program) from DCGI – India, UK MHRA, US FDA, EMEA, Vietnamese MoH, South Korean FDA, ANVISA – Brazil, WHO, MCC – South Africa etc. Led audits of investigator sites, clinical database, systems/process including Data services (DM, Statistical programming), Pharmacovigilance, computer system, CSR and of external vendor which includes but not limited to Bioanalytical labs, Drug depots, Phase I Units, CRO, EC, IWRS/IVRS and BA/BE centers. Worked in Pfizer, Inventive & Servicer Singapore.