Led a team responsible for qualifications and validations of processes, equipment, and systems, ensuring compliance with cGMP and regulatory standards. Directed investigations into deviations and non-conformances, implementing effective CAPA strategies to address root causes and drive continuous improvement. Delivered comprehensive training on cGMP, data integrity, and regulatory compliance to enhance team expertise and maintain high-quality standards. Conducted internal audits, prepared for regulatory inspections, and handled quality risk assessments to mitigate potential issues and ensure operational excellence.

Responsible for Qualifications, validations and re-validations of HVAC, Water system, Process Equipment, Process validation and vendor qualification.