I am a pharmaceutical professional with over 10 years of experience in Aseptic Batch Manufacturing, specifically in drug products, as well as in Computer System Validation (CSV) and Commissioning, Qualification, and Validation (CQV). I have a proven track record in managing the qualification and implementation of protocols for various stages, including User Requirement Specifications (URS), Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new equipment. My expertise extends to both drug substances and drug product manufacturing, particularly in vial lines. I am well-versed in regulatory standards, including 21 CFR 210/211, 21 CFR Part 11, and European regulations.