Atoosa Keshavarz
Computer System Validation Sr Development Chemist @Taro Pharmaceuticals
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WORK HISTORY
Computer System Validation Sr Development Chemist @Taro Pharmaceuticals
Brampton, ON, CA
EDUCATION
University of Toronto
Chemistry
Azad University (IAU)
Biochemistry and Biological Science
Centennial College
Environmental Chemistry
SKILLS
ABOUT ATOOSA KESHAVARZ
Continued my role from Taro Pharmaceuticals following its merger with Sun Pharma. Managed the implementation of new specialized pharmaceutical technologies and instrumentation to meet emerging regulatory demands and support new product portfolios. Executed the validation and integration of computer systems and advanced analytical instrumentation, leveraging cutting-edge solutions to enhance laboratory capabilities and ensure compliance with evolving regulatory standards.Experienced in computer system validation (CSV) with strong expertise in qualifying analytical systems, URS development, risk assessments, and IQ/OQ/PQ execution in compliance with FDA 21 CFR Part 11, GxP, GMP, and GLP. Validation experience spans GC-FID, HPLC, FTIR, GC-MS, LC-MS, ICP-MS, SprayTec, SprayView, NGI, Morphologi ID, and Raman spectroscopy. Proficient in Empower, MassHunter, OpenLab, ChemStation, LabSolutions, PerkinElmer, Malvern, Viota, and LIMS platforms.Skilled in method development, validation, transfer, and verification per ICH, USP, EP, JP, and BP guidelines using advanced chromatographic, spectroscopic, and elemental techniques. Managed analytical workflows including assay, impurity, residual solvent, and limit testing, along with SOPs, validation protocols, and technical reports. Experienced in OOS/OOT investigations, NCRs, deviations, and CAPA implementation, ensuring data integrity, regulatory compliance, and operational excellence across laboratory.
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