- Master of Science in Zoology from Bangalore University INDIA
- 18 + years of experience as Quality Assurance Personnel in Clinical Research Industry
- Leads all QA activities in Clinical, Pharmacovigilance, Bioanalytical Lab, Medical Writing, PK and Statistics and other units at NCS.
- Verifies compliance to the required regulatory requirements (GCP/GLP/GVP etc)
- Part of the team that organized the quality systems at the inception of NCS
- Involved in continuously improving quality systems at NCS
- Keeps track of regulatory and industry updates to ensure that systems and procedures at NCS meet the current required standards
- Faced regulatory audits by the FDA, WHO, EMA, ANVISA, MoH Turkey, and DCGI successfully
- Co-ordinates activities and responses from the operational units during regulatory and sponsor audits.
