From humble beginnings to global leadership in pharmaceutical quality, Ranjit Barshikar chronicles his extraordinary 55-year journey through one of the most transformative eras in the industry. In this deeply personal and insightful account, he shares the principles, challenges, and turning points that shaped not just his career—but the very systems and standards that define quality today.
A compelling narrative of integrity, innovation, and impact, Quality Trailblazer is both a professional memoir and a legacy of learning—for current and future leaders who believe that quality is not just a requirement, but a lifelong commitment.
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Ranjit Barshikar
Ranjit Barshikar is a globally acclaimed pharmaceutical quality visionary with over 55 years of pioneering leadership across Quality Management Systems, R&D, Manufacturing, and Global Regulatory Compliance (USFDA, EU, WHO). Recipient of top honours—including the “Quality Champion - Gold” Award by the Government of India and Lifetime Achievement Awards from the International UNICEF Council (USA) and Eminence Business Global Venture Group—he was named among the “100 Most Impactful Global Healthcare Leaders” by the World Health Congress and The Economic Times.
As CEO of QbD International, Mr. Barshikar leads global consulting on Quality by Design (QbD), CGMP, and Pharma 4.0. An Advisor to the UN’s Medicines Patent Pool, Geneva, and Editorial Board Member of the Journal of Generic Medicines (UK), he is an expert in AI, Machine Learning, and automation for Pharma 4.0. His extensive auditing and regulatory experience span sterile and non-sterile formulations and APIs across India, USA, EU, Saudi Arabia, China, Brazil, and beyond. A prolific speaker, he has delivered over 545 presentations worldwide and 150+ webinars since 2020. Widely published in leading journals, Mr. Barshikar continues to shape global pharmaceutical quality standards and mentor future leaders in the industry.
