Highly motivated, result oriented, dedicate to on-time delivery, strong analytical concepts with team building and team player skills.Implementation of cGMP and GLP in quality control department.Handling of agencies, customer and CDSCO audits. Knowledge of analytical technical tools like GC, HPLC, IR, ICP, IC, PSD and LC/MS and GC/MS, SEM, TGA, DSC, XRD etc.Method validation of Raw materials, intermediate, API, Cleaning and elemental impurities. Method verification and method transfer. Characterization, Qualification and management of reference standard and working standard. IQ, OQ and PQ of sophisticated instrumentsCSV, Challenge test of software and calculation.Verification of software as per 21CFR part 11.Calibration, preventive maintenance and troubleshooting of laboratory instruments. Stability study of drug substance and extrapolation of retest date.Handling of OOS, OOT, deviations, Incidents, root cause investigation, Change control and CAPA.Handling of customer’s complaint and queries. Quality Risk management, Risk assessment and CAPA. Management review meeting (MRM)