Yashwitaa Davluri

Quality Specialist, Small Molecule Cmc Compliance - Product Complaints @Vertex Pharmaceuticals

Process incoming clinical and commercial product complaints, including intake, initial evaluation, and triage. Author product complaint investigations and coordinate with CMOs for external investigations and coordinate sample returns and complete sample evaluations -Perform Root Cause Analysis and identify corrective actions -Conduct triage meetings and escalate critical issues to senior management - Complete monthly reconciliation reports - Provide training to cross functional teams (both internal & external) on the product complaint process - Assist with generation of quarterly trend reports and applicable sections of Annual Product Reviews and CMC Quality leadership team in preparing for audits and inspections associated to PCs.