M Vijay

WORK HISTORY

EDUCATION

ABOUT M VIJAY

I am an experienced Quality Control Analyst with over 5 years in the pharmaceutical industry, focusing on quality control, method development, and validation. My background encompasses a wide range of technical and compliance issues, including OOS investigations, deviations, out-of-trend assessments, and CAPA systems. I facilitate effective communication across various levels and divisions, ensuring adherence to quality standards.In my current position as a Senior QC Analyst at Aurolife in New Jersey, I lead the analytical development and validation of methods to support our new product filing initiatives. I possess extensive expertise in analytical techniques such as HPLC, GC, dissolution, IR, UV, TLC, and Karl Fischer and conducting particle size analysis, chromatographic purity evaluations, and friability testing. My role includes overseeing the testing of raw materials, in-process materials, and finished products, ensuring compliance with USP/EP standards. Additionally, I manage the stability program for the analytical development of new products aimed at ANDA filing, facilitating successful product launches.I also served as a QC Analyst at Sage Therapeutics I honed my skills in testing raw materials, finished products, stability samples, and water samples. I adhered to established SOPs and USP methods to ensure product quality for release. My responsibilities included calibrating laboratory equipment, maintaining HPLC systems, and executing various wet chemistry techniques, including titration and dissolution. I also contributed to data integrity initiatives through LIMS, conducted laboratory investigations, and participated in internal inspections and audits.I hold a Bachelor’s degree in Pharmacy from Rajiv Gandhi University in India. With a strong commitment to ensuring product quality and compliance within the pharmaceutical sector, I continuously seek to expand my skills and knowledge.