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About me
I am a GMP Auditor and Pharmaceutical Quality Professional with over 10 years of experience across API, formulation, packaging materials, and pharmaceutical quality systems.
Throughout my career, I have worked in Quality Assurance, Change Control, Supplier Qualification, and Corporate Quality, gaining hands-on experience with both manufacturing operations and regulatory compliance.
Currently, I work in Corporate Quality Assurance, where I manage supplier qualification activities, perform GMP audits, review quality systems, evaluate CAPAs, support regulatory inspections, and contribute to the development of corporate quality procedures.
As part of my auditing experience, I have conducted more than 20 on-site GMP audits and over 30 remote audits of pharmaceutical manufacturers and suppliers across India and internationally. I have audited organizations including, Cipla, Divi's Laboratories, Glenmark Pharmaceuticals, Cadila Pharmaceuticals, MSN Laboratories, Laxai Life Sciences, and several other API and pharmaceutical manufacturing facilities.
I have also performed supplier audits on behalf of international pharmaceutical companies and sponsors, evaluating manufacturers located in India, China, Turkey, and Thailand.
My experience spans supplier qualification, Quality Management Systems (QMS), production, laboratories, warehouses, utilities, engineering controls, documentation practices, data integrity, and CAPA effectiveness. I have worked with quality systems aligned with USFDA cGMP, EU GMP, WHO GMP, ICH Guidelines, PIC/S GMP, and ISO quality principles, helping organizations strengthen compliance while maintaining practical, risk-based approaches.
Beyond auditing, I enjoy simplifying complex GMP concepts for pharmaceutical professionals. Through my educational content, I share practical lessons from audits, regulatory expectations, warning letters, and real-world quality challenges to help professionals build stronger technical understanding rather than simply memorizing regulations.
If you're looking for guidance on GMP audits, supplier qualification, pharmaceutical quality systems, regulatory expectations, CAPA effectiveness, or building a career in pharmaceutical Quality Assurance, I'd be happy to connect and share practical insights from real industry experience.