Nitin Gadekar

Background

About Nitin Gadekar

I'm a highly driven pharmaceutical professional with a rich background spanning nearly a decade in the realm of Quality Management and Regulatory Compliance. My expertise encompasses a wide array of areas, including Change Control, CAPA, Manufacturing & Market Complaint Investigation, Product Recall, FAR, Audit & Compliance, APQR, Vendor Management, Tech.Transfer, Risk Management, Quality Operations, and Regulatory Compliance. Pharmaceutical Expertise:Throughout my career, I've successfully led and contributed to a variety of projects, ranging from TrackWise and Documentum Implementation to retrospective assessments of deviation, market complaints, product assessments, and Control Sample evaluation. I've been instrumental in the implementation of new SOPs and guidelines, ICHQ3D, NMDA Impurity risk assessments, Excipient risk assessments, and staying up to date with Pharmacopeia updates. International Exposure:I've taken my skills global by conducting international API KSM vendor audits, including visits to manufacturing sites in Hilar and Shenyang, China. This exposure has enhanced my ability to navigate the diverse landscape of pharmaceutical manufacturing and compliance. Analytical Prowess:My background includes experience in pre-formulation, formulation development, and bio-analytical & analytical method development. I've successfully developed and validated analytical methods for various drug molecules in blood and rat plasma, contributing to the precision and quality of pharmaceutical products. Regulatory Acumen:I'm well-versed in the regulatory requirements of the US, Europe, Canada, and South Africa. My experience includes handling new product filings, addressing regulatory queries and responses, and conducting GxP assessments of computerized systems to ensure compliance with international standards. Projects of Note:FDA Remediation, retrospective evaluation of Investigation, and product evaluationPharmaceutical Quality System (PQS) Development & Implementation Corporate Policy and GovernancePharmacopeia Update, Implementation of ICHQ3D, Risk evaluation of NMDA Impurities, and Risk assessment of Excipients.Reduce/Skip testing program for API, Excipient In-process and finished products