Praveen Sawant

Quality Specialist @Pinewood Healthcare

IE

To monitor the implementation and compliance with Current Good Manufacturing Practice (cGMP) principles and to propose necessary corrective measures.• Responsible for Review of executed Batch Manufacturing/Packing Record at site and submission to QP for Batch Release.• Responsible for internal audits at site and compliance to SOPs, GMP.• Responsible for Deviation and root cause analysis at site. • Evaluating and assessing changes in process, facility, products, equipment and implementation of changes and verifying effectiveness.• Responsible for CAPA Management at site• Responsible for preparation of system SOPs (Deviation, Change control, Market Complaints, Data Integrity,Internal Audits,Handling of Quality Defect, Calibration).• Responsible for gap analysis based on different regulatory guidelines to update the policies and procedures in quality systems• Responsible for Audit and Compliance report for Customer Audits.• Responsible for preparation of Annual Products Quality Reviews and drawing conclusions • Responsible for Handling of Product Recalls at site• Responsible for Handling of Market Complaints and investigation• Responsible for Risk Assessment and Risk Management• Active Part of Quality Management System (Change control management, OOS, CAPA, Quality Risk Management) & cGMP Compliance. • Supplier Qualification/Re Qualification - Review the Questionnaire, Vendor Audit, CAPA audit report issued by supplier and maintain the approved supplier list.• QA Trainer for SOP’s (Deviation, Change control, Market Complaints, Data Integrity,Internal Audits,Handling of Quality Defect, Calibration) • Review, Approval and Training of SOP’s, cGMP modules, Data Integrity.• Responsible for development and implementation of quality management system at the site and continuous improvement.• Supplier Qualification/Re Qualification - Review the Questionnaire, Vendor Audit

Goa University

Bachelor of Science - BS, Chemistry

Kuvempu University, Shankaraghatta, Shimoga

Master of Science - MS, Chemistry