• Have experience in QA audit.• Faced audits from regulatory agencies of United States Food and Drug Administration, Medicines and Healthcare products Regulatory Agency (U.K), South Africa-Medicines Control Council (MCC), Brazil-Brazilian National Health Vigilance Agency (ANVISA) and Australia-Therapeutic Goods Administration (TGA)• Managed Internal Audit• Initiated Preventive maintenance & Calibration Schedules• Managed Validation Process for Quality Control• Prepared and handled Cleaning Validation, In-Process Documents, Finish Product Documents, Preparing and Checking Standard Testing Procedure, and Specification Document• Prepared Impurity Profile, Dissolution Profile, Raw material, and Finished Product Certificate of Analysis• Prepared and Reviewed documents and updated as per current Pharmacopeial version• Managed pre and post approval protocol• Checked Analytical Method Validation Report. • collect all the documents required for ANDA submissions. • performed ANDA submission AND responds to FDA query • applied for CBE-30, CBE-0 and PAS. • performed period review of ANDA labels • submits PADER got approved ANDA • submits annual product review for approved ANDA • performed supply chain management for approved ANDA • support in new ANDA launchSpecialties: Quality Assurance and Regulatory affairs