Prashant Mengshetti

Biography

Accomplished, results-oriented Quality Professional with over fourteen (14+) years of extensive industry experience in the area of Quality Assurance & Compliance, Supplier Audits, Manufacturing, Technology Transfer and Operations Training. Possess excellent technical and compliance background with observation, investigative and interpersonal skills. Core Competencies: Quality Assurance & Compliance, Supplier Management, Supplier Audits, Mock PAI, Due Diligence, Internal Audits, CAPA Management, Supplier Corrective Action Reports (SCARS) Investigation, Change Management, Deviation Management, Development/Revision of SOP, Validation, Technology Transfer, Technical/Operations Training, Manufacturing Operation, Operation Excellence, Batch Release.

Research Interest

 Supplier Management: Planning, execution, reporting, tracking, and completion of supplier audits for Finished Dosage / API / Testing (GLP) / C&FA / Primary & Secondary Packaging components manufacturing. ★Quality Assurance & Compliance: Devising and implementing company quality assurance program in compliance with cGMP requirements. Prioritizing quality assurance responsibilities based on the integration of new designs and products into current production schedule. Partner with suppliers to identify appropriate Corrective and Preventative Action Plan (CAPA) to address any findings identified during audits and Health Authority Inspections. ★Team Management: Managed and Coached team of 27 Quality Assurance Personnel. Provided administrative and technical direction to all quality assurance personnel encompassing personnel administration, resolution of technical problems, development / approval of in-house training, etc. ★Played key role in global cGMP Compliance and successfully faced audits:US-FDA, UK-MHRA, ANVISA, TGA-Australia, MCC-South Africa, WHO-Geneva, NDA Uganda and various other countries like Ukraine & Germany etc.