Mandar Kulkarni

Background

About Mandar Kulkarni

A seasoned pharmaceutical production professional with over 15 years of experience in driving operational excellence within USFDA, UK-MHRA, and WHO-approved facilities. I specialize in the manufacturing of oral dosage forms (tablets, capsules) and have a proven track record in ensuring compliance with regulatory standards, leading validation processes, and preparing for global audits. With expertise in equipment qualification, process validation, and cross-functional team leadership, I have successfully optimized manufacturing processes, reduced cycle times, and enhanced productivity. My deep understanding of cGMP regulations and strong problem-solving abilities have contributed to creating safe, compliant, and efficient production environments. Whether it's managing complex production lines or leading audit preparations, I am dedicated to maintaining the highest standards of quality and safety while delivering cost-efficient results. Key Skills: • Pharmaceutical Manufacturing (Tablets, Capsules) • Process & Cleaning Validation (IQ, OQ, PQ) • cGMP Compliance & Quality Assurance • SAP PP Modules & E-QMS (TrackWise) • Regulatory Audits (USFDA, MHRA, WHO) • Cross-Functional Leadership • Equipment Qualification & Calibration • Process Optimization & Continuous Improvement