Sanjay Kawale

Background

About Sanjay Kawale

A competent professional with19 years of experience in Formulation Research & Development, New Product Development, Documentation and People Management • Dexterous in organizing, planning and coordinating the entire product development activities; worked on the development of Immediate Release, Dispersible and Orodispersible, Delayed Release and Extended- Release Product • Deft in maintaining all the documents & daily calibration records and contributing in the developmental activities • Gained exposure to understand several Bio Equivalent Study Designs which suitable for different BCS class drug product • Well-versed with ICH & Regulatory Guidelines for developing regulatory market drug products • Expertise in planning and monitoring several projects at various levels viz, requirement study, resource allocation, etc. • Keen to make a career in ANDA projects. Core Competencies • Monitoring quality control in various formulation operations and implementing systems for improving processes • Supervising the spectrum of activities sp byanning testing, quality control and coordination with cross-functional departments to complete various projects on time • Maintaining knowledge of state-of-the-art research techniques, technology, equipment and/or systems • Scale-up/Process optimization and Exhibit/Validation bathes as per regulatory requirements • Utilising various types of patents like formulation method in different assignments • Undertaking Pre-formulation (API Characterization and Drug-Excipient Compatibility) studies • Creating and updating DPDM reports