Vidya Gorule Email and Phone Number

analytical method validation protocol and report review

Working in AJANTA PHARMA LTD R&D Center Mumbai in Analytical Method Development (AMD) Division, Acquainted in analysis of Formulated Drug Product and API which includes Tablets, Capsules etc. which is mainly marketed in US, EUROPE, Domestic & different part of the world.Responsibilities & Area of Work:Review of Analytical Method validation raw data, protocol and report data.Reviewing analytical data for routine analysis.Handling of Discrepancy and its investigation.Handling of incident, deviation and change control.Working on Instrument such as HPLC, GC, GC-HSS, Dissolution, FT-NIR etc.Performing Method Development, Method Validation on Near IR Spectroscopy.Performing Dissolution, Assay, Blend Uniformity, Uniformity of Content.Perform Method Validation of Finished Drug Product for Residual Solvent, Assay and Dissolution.Perform Method Validation of API for Residual Solvent & Related Substance on GC, GC-HSS instrument.Performing timely analysis of development stability batches of formulated drug product as per Specification.API Method Verification.Worked on Analytical Method Development for API on GC, GC-HSS and its workability.Operating, calibration and maintaining departmental equipment and instrument as per SOP.Implement corrective actions as required.LNB recording and preparation of product development reports.Preparing/ Reviewing Protocols and reports for method validation.Ensuring Compliance to quality standard & cGMP also cGLP required during the Work.Major Achievements:CU, BU and Assay Development on NIRImplemented Quality Systems as per cGMP and cGLP requirements.Analytical Tools:Checking Percentage active and Preservative : HPLC, GCChecking Formulation of Tablets : Dissolution Bath. Residual Solvents in Finished Product & API : GC Instrument (Agilent)Checking moisture in tablets : Autotritrator (Karl Fisher)Database Server : Open LabDatabase Server For FT-NIR : Opus Lab 8.1