MAHESH PUDIPATI

A highly skilled and results-driven QA professional with over 17 years of progressive experience in quality management and process improvement within the pharmaceutical industry. Demonstrates a proven track record of driving successful initiatives that enhance operational efficiency, ensure regulatory compliance, and improve product quality. Known for a keen analytical mindset, exceptional organizational abilities, and a meticulous, detail-oriented approach to problem-solving. Possesses a creative and inquisitive nature with a strong ability to analyze complex information and optimize processes. Seeking a challenging position that allows me to leverage my extensive expertise while contributing to the growth and success of a forward-thinking organization.

• Spearheaded process improvement initiatives for the Urapidil Coating, reducing cycle time from 45 days to 30 days, significantly enhancing operational efficiency.
• Recognized with the Dr. Reddy’s Chairman Excellence Award for leading the Best Quality Driven Team, showcasing dedication to operational excellence and quality.
• Awarded the Dr. Reddy’s Bravo Award for the successful implementation of privilege management across all equipment at the FTO 3 Site, improving regulatory compliance and system integrity.
• Achieved Lean Six Sigma Yellow Belt certification, demonstrating a strong foundation in process optimization and continuous improvement.
• Trained and certified by a USFDA retired auditor in technical report writing, enhancing documentation standards and regulatory adherence.
• Completed specialized training by LACHMAN Consultants on a systematic approach to Incident Investigations, improving root cause analysis and corrective actions.
• Certified as a DNV Auditor for Integrated Environment & Occupational Health Safety Systems, ensuring compliance with ISO 14001:2015 & OHSAS 18001:2007 standards.

• Successfully achieved GMP certification from the National Drug Authority (NDA), Uganda for the facility for the first time, ensuring full compliance with regulatory standards.
• Provided extensive support to regulatory authorities, effectively coordinating and resolving all queries related to product registrations with NDA Uganda.
• Successfully led the launch of Metformin tablets in the market, ensuring complete regulatory, quality, and documentation readiness for timely commercialization.