Ambika Kulkarni is a pharmaceutical quality and validation specialist with over 19 years of experience in quality assurance, computer systems validation (CSV), equipment qualification, and QMS implementation. She holds a Master’s degree in Pharmacy (Quality Assurance Techniques) and currently serves as the Manager – Quality and Validation at Vita Scientia Globus Pvt. Ltd. (VSGPL).
At VSGPL, Ambika plays a pivotal role in managing validation projects across global pharma and biotech clients. Her portfolio includes overseeing risk assessments, SOP development, validation master plans, FAT/SAT documentation, and qualification protocols for systems ranging from cleanroom equipment to enterprise digital platforms like SAP and eLMS. She has led projects for prominent clients including Biocon, Pfizer, Dr. Reddy’s, Enzene, and many others across India, Israel, Singapore, and Malaysia.
Ambika’s approach integrates technical precision with regulatory compliance, ensuring alignment with global standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. She is also actively involved in team mentoring and client communication.