Highly motivated and detail-oriented Project & Process Management professional with almost 9 years of experience in steering complex projects and guaranteeing regulatory compliance. Demonstrated proficiency in fostering continuous improvement through adept data analysis and process optimization. Possesses robust technical ability in QMS, ISO/IEC, SDLC, CSA, GxP and ICH guidelines, coupled with excellent communication and collaboration abilities. Eager to leverage proven expertise in a project management capacity for successful project delivery and organizational growth.Key Skills Project Management: Planning, execution and monitoring of projects, risk management, RCA, CAPA, KPI analysis and reporting. Regulatory Affairs: Dossier preparation, technical data review, regulatory submissions, technology transfer and internal/external audits. Quality Assurance: System development, document review, audit participation, data analysis and process improvement. Technical Skills: QMS, SDLC, PDLC, CSV, CSA, GxP, D.M.S., ICH guidelines, Medical Devices, SaMD, Biosimilars, Biologics, Pharmaceuticals, MDD-MDR, US-FDA, 510K, CDSCO, Agile, JIRA, GIT, Sharepoint, Smartsheet, MPP and Microsoft Suite. ISO/IEC Standards: (13485, 14971, 62366, 27001-ISMS, 62304, 9001, 45001, 14001)