22 years of combined experience in GxP-Quality Assurance and Clinical Operations. Proficient with Project Management Methodologies in BA/BE Studies and Clinical Trials. Technically Sound, with Excellent Communication, Presentation skills and Training skills. Direct working experience with Clients from - USA, Belgium, Finland, Italy and Switzerland. Clinical Study Audits with Regulatory scope: USFDA and EU. Certified ISO 9001:2008 for QMS and ISO 27001:2005 for ISMS. Certified Six Sigma Black Belt: for Quality Improvement Methodologies. 50+ Multicentric Clinical Trials Site Monitoring and Site Audits. Therapeutic Segments covered: Oncology, Diabetes, Orthopedic segment, Cardiovascular, Respiratory, Ophthalmic and Neutraceuticals. Approximately 120 BA/BE Study Audits conducted in various Indian CROs. Imparted training on Drug Development, Regulatory Guidelines, GCP, GCLP and QMS. Conducted GCP Systems audit of CROs (full service) in India. Worked as Consultant to Department of Biotechnology for development of Clinical trial sites in India. Conducted Fraud Investigation for 16 USFDA submission studies in India. Clinical Auditing and Monitoring Services: Clinical Trials and BA/BE. CRO/SMO/Site Qualification for BA/BE Studies and Patient based PK & PD studies. Data Integrity evaluation of BA/BE Studies and Patient based PK & PD studies. Risk based monitoring services for patient-based PK & PD studies. Imparted training on Drug Development, Regulatory Guidelines, GCP, GCLP and QMS. Language proficiency (speaking reading and writing)- English, Hindi and Bengali. Based in Hyderabad.