

Results-driven Pharmaceutical Quality Assurance and Analytical Professional with experience in Quality Assurance, Quality by Design (QbD), Analytical Development, and Pharmaceutical Regulatory Affairs within reputed pharmaceutical organizations. Experienced in the review and approval of MFRs, STPs, Specifications, SOPs, Qualification Documents, COAs, OOS/OOT investigations, Change Controls, CAPA, and other Quality Management System (QMS) activities. Currently working as a Development Quality Assurence Executive at Gufic Biosciences limited Research and Development Centre and previously associated with Lupin Limited in QbD and analytical functions.
Possess strong expertise in analytical testing of oral solids, ophthalmic, high-potent, contraceptive, and sterile pharmaceutical products, including assay, content uniformity, dissolution, degradation products, blend uniformity, particle size analysis, osmolality, viscosity, and HPLC calibration. Skilled in handling regulatory submissions, product permissions, import licenses, COPP applications, and interactions through ONDLS, MPFDA, and NSWS portals.
Proficient in operating and troubleshooting analytical instruments including HPLC, UV-Visible Spectrophotometers, Dissolution Testers, Karl Fischer Titrators, Malvern Particle Size Analyzers, Osmometers, and Viscometers. Well-versed in cGMP, GLP, data integrity, documentation practices, laboratory investigations, and regulatory compliance. Strong leadership, communication, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality excellence and continuous improvement initiatives.
GPA: 57.53