At ICON plc, I provide quality support across clinical studies, including risk-based TMF assessments and checks of study documentation. My work helps identify record issues before audits and inspections.
I support sponsor audits and regulatory inspections by reviewing evidence, coordinating query responses, and tracking actions. I also investigate quality issues, support root cause analysis, and monitor CAPA effectiveness and closure.
At ICON plc, I contributed to a 36% reduction in audit findings through proactive quality oversight, risk-based assessment, and remediation follow-up. I also analyze quality trends and recommend process improvements.
Previously, I supported TMF operations at ICON plc and held quality assurance roles at Teyro Labs Pvt Ltd, Regenix Biosciences, and Pfizer. At Teyro Labs Pvt Ltd, I led a 2–3 member QA documentation team and supported a US FDA inspection for the documentation area, completed with zero observations.
