
Accomplished Senior Scientist with a proven track record at Vimta Labs, specializing in Extractable and Leachable Studies. Expert in method development, validation, and regulatory support, with proficiency in GC-MS instruments. Demonstrates exceptional communication, flexibility, and a rapid learning curve. Achieved significant improvements in study execution efficiency.
Design Extractable and Leachable Studies, and Develop methods and ensure study execution in a timely manner
Performing Extractable and Leachable Study lead the day-to-day operation of the E&L activities
Develop and Validate Analytical Methods and appropriate Specification for leachable testing
Provide regulatory filling support and draft responses to regulatory queries pertinent to E&L Studies
Handling two different makes of GC-MS
Instruments(Agilent&Shimadzu)
Well versed with Handling hardware,software and trouble shooting aspects of major analytical instruments
Analyzing and investigating the out of Specification
Periodic Calibration of Analytical Instrument Like GC-MS
Analysis of Active Ingredients (API),Intermediates and Formulation Finished Products
Responsible For Performing impurity for R&D,AR&D Support
Analysis Supporting to the regulatory deficiency According to their needs
Responsible for the study of Genotoxic Impurities and Carryover Studies as Regulatory Requirements
Supporting Batch analysis for plants
Well versed with Handling hardware,software and trouble shooting aspects of major analytical instruments
Analyzing and investigating the out of Specification
Good communication skills
Flexible,Hard working,Honest and Determination
Perseverance and ability to learn the new concepts quickly
ability to lead others in demanding circumstances and remain calm in the stressful situation