Raghukul Chaudhary

Quality Assurance Analyst @Vantive

Gurugram, IN

Create and manage quality documents using TcU (Product Lifecycle Management Software) to ensure compliance and accuracy in product development and regulatory processes for kidney care therapies.• Execute change control processes in TrackWise, ensuring all product, process, or system modifications are evaluated, approved, and documented per regulatory and quality standards.• Process customer complaints from India, Nepal, Sri Lanka, and Bangladesh in TrackWise, conducting root cause analyses and implementing corrective actions to ensure product safety and reliability in acute and renal therapies.• Initiate Non-Conformance (NC) reports in TrackWise, identifying and documenting deviations from quality standards, and facilitate resolution to maintain product and process integrity.• Manage Corrective and Preventive Action (CAPA) processes, developing and implementing action plans to address root causes of non-conformances and prevent recurrence, enhancing quality system effectiveness.• Support internal audits using TrackWise 9, documenting findings and proposing corrective actions to ensure compliance with ISO 13485 and other applicable regulatory standards.• Coordinate product holds, identifying and isolating non-conforming products to prevent distribution and uphold quality standards for kidney care products within the India region.• Prepare aging reports for complaints across the APAC region in TrackWise, analyzing resolution timelines and reporting trends to drive timely corrective actions and continuous process improvements.• Ensure adherence to Vantive’s quality management system (QMS) and ISO 13485 through meticulous record-keeping, process monitoring, and collaboration with regional and cross-functional teams.• Contribute to developing and updating standard operating procedures (SOPs)

Lovely Professional University

Bachelor's degree, Biotechnology

AMITY University Gurgaon

Master's degree, Biotechnology