Conduct analysis of raw materials, intermediates, finished APIs, stability samples, cleaning validation samples, and utilities as per approved specifications and test methods. Operate, calibrate, troubleshoot, and maintain analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer, TOC Analyzer, and dissolution systems, where applicable. Prepare and standardize reagents, volumetric solutions, reference standards, and test solutions as per approved procedures. Review chromatograms, analytical data, calculations, and laboratory records for accuracy and compliance. Execute analytical method validation, method verification, method transfer, and stability studies as assigned. Investigate laboratory incidents, deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) results; support implementation of CAPAs. Ensure compliance with cGMP, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and data integrity principles (ALCOA+). Maintain laboratory logbooks, instrument usage records, calibration records, and electronic data systems such as LIMS and Empower. Coordinate with Production, Quality Assurance, Warehouse, and Engineering teams to ensure timely sample analysis and batch release.
