Santhosh Kumar Pudi

About Santhosh Kumar Pudi

I possess a cumulative experience of 15 years 10 months in various roles within the Biopharmaceutical and Pharmaceutical industries. Presently, I am employed at Jodas Expoim Private Limited, where I lead a team of 33 members as the Team Lead for Quality Assurance (QA)- Validation. My responsibilities encompass global validation and qualification for projects involving onco and general injectables, stents, and monoclonal antibody manufacturing in both Russia and India.Before joining Jodas Expoim, I served as the validation Head at Genbio Science Private Limited. QA head at Brilliant Biopharma Pvt Ltd. In these roles, I oversaw In-Process Quality Assurance (IPQA), Quality Management Systems (QMS), and project-related activities. My team consisted of 27 members, including Assistant Managers and Senior Executives. I led the team in handling National and International regulatory audits, ensuring timely compliance, conducting investigations, implementing change controls, and addressing CAPAs. Additionally, I managed project-related tasks such as equipment validations and quality risk management.Prior to this, I worked as an Assistant Manager at VINS Bioproducts Pvt. Ltd for 2 years, where I played a crucial role in Quality Assurance (QA) activities, including document reviews, deviation management, and equipment validations. I also briefly served as In-Charge of QA Validation at Gland Pharma Ltd.Throughout my career, I\'ve been involved in various projects, including support for Hepatitis B production and multiple production line projects in Gland Pharma Ltd. Notably, I worked with Dr. Nora & Victor Macquade, Ex Auditors of WHO Geneva, during the WHO anti-sera Prequalification project at VINS bioproducts.Over the years, I\'ve been subjected to numerous audits from regulatory bodies such as USFDA, MHRA, WHO, Local WHO GMP, GMP & GLP, and customer audits complying with FDA and PICS requirements in countries such as Kenya, Philippines, Saudi Arabia, Indonesia, Jordan, and Thailand. Additionally, I\'ve faced audits from Drug authorities, Sanofi Corporate, and NAFED inspections, as well as audits related to new product manufacturing licenses.Regarding my education, I earned a Master\'s degree in Microbiology from Andhra University in 2009 and completed my Bachelor\'s degree in 2007.

Experience

1. General Manager

   Qualitus Pharma Solutions

   Dec 2025 — Present · Hyderabad, IN

   GM qualification and validations

Education

• Andhra University

  M.Sc, Microbiology

  2007 — 2009