Nandavihari Chodisetty
CMO Manager External Manufacturing Qa @Dr. Reddy's Laboratories
Signup · Get unlimited contacts
WORK HISTORY
CMO Manager External Manufacturing Qa @Dr. Reddy's Laboratories
Hyderabad, IN
Directed end-to-end quality governance for 15+ contract manufacturing partners, aligning operations with global GMP and QMS mandates.• Championed site readiness for regulatory inspections by USFDA and EU-GMP bodies, offering strategic audit planning and compliance support.• Streamlined the review and approval cycle for batch records, validation protocols, and Certificates of Analysis, enhancing turnaround efficiency.• Led investigations into OOS, OOT, and product complaints, ensuring rigorous root cause analysis and robust CAPA deployment.• Coordinated multi-site technology and product transfers, ensuring flawless execution of validation and launch batches.• Partnered with RA and SCM to synchronize batch release timelines and regulatory submissions across external sites.• Crafted and maintained Quality Agreements, clearly defining roles, responsibilities, and compliance expectations with CMOs.• Mentored QA teams and external partners on GMP compliance, data integrity principles, and audit documentation best practices.
EDUCATION
Dr. M.G.R. Educational and Research Institute
Bachelor of Pharmacy (B.Pharm)
Jawaharlal Nehru Technological University
Master of Pharmacy (M.Pharm) , Pharmaceutical analysis and Quality assurance
ABOUT NANDAVIHARI CHODISETTY
I am a results-driven pharmaceutical quality professional with over 14 years of progressive experience across External Manufacturing Quality Assurance (QA), Analytical QA, and Quality Control within highly regulated, global environments. Currently serving as CMO Manager – External Manufacturing QA at Dr. Reddy’s Laboratories, I lead quality oversight for 15+ CMOs, ensuring full compliance with GMP, QMS, and international regulatory standards including USFDA and EU-GMP.My core expertise lies in regulatory audit readiness, batch review and disposition, OOS/OOT investigations, analytical method validation, and change control management. I have a proven track record of driving operational excellence and compliance through robust quality frameworks, strategic partner engagement, and meticulous documentation practices.Over the years, I have successfully led cross-functional teams during site transfers, validation programs, and inspection preparedness, while streamlining documentation processes to reduce cycle times and enhance audit outcomes. I am passionate about embedding a culture of quality, integrity, and continuous improvement, while staying attuned to evolving regulatory landscapes and digital tools like Empower, Chromeleon, OpenLab CDS, and LIMS.Fluent in five languages and recognized for collaborative leadership, I continue to contribute to pharmaceutical quality excellence with a proactive, detail-oriented, and solution-focused mindset.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.