Mahesh Pandhare

Background

About Mahesh Pandhare

As an enthusiastic and detail-oriented Executive with over 5 years of experience in the pharmaceutical and biotechnology sectors, I specialize in Computerized System Validation (CSV), regulatory compliance, and quality management systems (QMS). I have a strong track record in ensuring adherence to 21 CFR Part 11, EU Annex 11, and other global standards such as TGA, USFDA and EMA. My role at Syngene International Limited has been pivotal in managing and validating computerized systems, ensuring compliance with regulatory requirements related to electronic records and electronic signatures. With a Bachelor’s in Biotechnology and a Diploma in Engineering from VJTI, I have continuously enhanced my expertise through certifications in Six Sigma, Agile Methodology, and Python for Non-Programmers. These skills have enabled me to manage complex compliance projects, digitalize QMS processes, and implement system improvements using platforms like WERUM PAS-X and SAP. Key Areas of Expertise- Computer System Validation (CSV): Expertise in validating computerized systems for pharmaceutical production, ensuring adherence to regulatory guidelines like 21 CFR Part 11 and EU Annex 11, including electronic record management, electronic signatures, and audit trails- Audit Management & Compliance: Leading audits by regulatory bodies (TGA, USFDA, EMA) to ensure compliance with GxP standards. Experience with ensuring systems meet global regulations and conducting audits on QMS and CSV processes- Digitalization of QMS: Proficient in utilizing tools such as WERUM PAS-X and SAP to streamline operations, automate workflows, and improve quality systems- Vendor & Risk Management: Managing vendor relationships and assessing risks related to the implementation and maintenance of computerized systems to ensure data integrity and system compliance- Continuous Improvement & Process Optimization: Leading initiatives for continuous improvement, driving quality projects like eBMR and Immunome, and successfully optimizing systems for enhanced operational efficiency- Software/Tool Proficiency- • MES - Werum Pas-X • LIMS • SAP • Pharmaready eDMS • Caliber eDMS • JIRA • QEdge QMS & SOP • Docusign • Dochub • Valgenesis • Validator Professional Achievements: Enzene Award for BBM-QA Recognized as a Good Team Player for eBMR Commended for work on the Immunome Project Well Done Buddy recognition for contributions to the Fun Factory initiative EPIC Ratna for enhancing quality culture at Intas Biopharma Pvt. Ltd.