I have eight years of experience in the Pharmaceutical drug development primarily comprising of Clinical Quality Auditing and Quality Management System establishment. Also Project Management including metrics, People Management, Monitoring and Compliance Oversight in Clinical Research Industry.
IRCA Approved ISO 9001:2008 Lead auditor (QMSLA/13/18/0098)
Specialties: Auditing of Clinical projects as well as Processes of the organization, Clinical Operations, Training, Resource Planning and allocation, Inspection readiness, Process Development, Representing the Organisation in regulatory inspections like USFDA, ANVISA, WHO, ANSM (AFSSAPS), DCGI and Client audits
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