Pramod Chavan

Experience

1. Quality Assurance Executive

   Sandoz

   Apr 2022 — Present · Mumbai, IN

   Undertaking review and endorsement of Standard Operating Procedures (SOPs), conducting thorough Product Quality Reviews, and carrying out precise In-Process Quality Assurance (IPQA) activities to ensure unwavering adherence to regulatory and Quality Management System standards.• Vigilantly monitoring shop floor operations for compliance, pivotally tracking quality and compliance issues, and driving prompt resolutions and follow-up actions during performance meetings.• Conducting meticulous reviews of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) within the Manufacturing Execution System (MES) & effectively coordinating batch releases in SAP for seamless further processing, guaranteeing careful adherence to protocols.• Assuring comprehensive assessments of Facility Qualification, HVAC Qualification, Laminar Air Flow (LAF) Qualification, and Water System Qualification activities, while precisely evaluating maintenance work requests to identify potential quality impacts on products.• Offering strategic assistance to the Market Complaint Investigation Team in achieving audit compliance, conducting thorough complaint investigations, and facilitating effective Corrective and Preventive Action (CAPA) implementation, thereby ensuring steadfast regulatory compliance and enduring customer satisfaction.• Instrumental in reviewing and authorizing Process Validation protocols and reports for both new and existing products, ensuring the establishment of robust processes and full compliance with regulatory mandates.• Conducting comprehensive Self Inspections and Vendor Audits to uphold stringent regulatory compliance and the highest standards of quality.• Exercising scrutiny over protocols and reports for Hold Time Studies, ensuring strict adherence to regulatory guidelines and industry best practices.• Conducting sampling for Cleaning Validation activities and Blend Samples, guaranteeing the utmost cleanliness and integrity of products.

Education

• University of Northampton

  Master of Business Administration - MBA

  2017 — 2018

• Shivaji University Kolhapur

  Bachelor’s Degree

  2006 — 2010

• Global Institute Of Regulatory Affairs Pune

  Post Graduate Diploma In Regulatory Affairs

  2015 — 2016