Raman Tkram

Experience

1. Manager Method Validation & Routine Release Analysis

   Syngene International Limited

   Dec 2008 — Present

   In charge and Management of samples for GCMS, LCMS, LCHRMS, ICP-OES, ICPMS, IC, DSC, TGA and DVS technique. Handling of release activity of Peptide, oligo nucleotide, Semaglutide, Liraglutide, Tirzepatide and type 2 diabetics drugs by LCMS and LCHRMS. Method development for Identification of Oligo nucleotide and peptide molecules by LCMS and LCHRMS Method Development, Validation and release of Nitrosamine impurities by LCMS Managing Method validation and routine release for Genotoxic impurities by HPLC, GCHS, GCMS and LCMS Managing method validation and Routine analysis of ICP-OES and ICP-MS Extractable and Leachable studies for packaging materials and containers Physico chemical properties, polymorphism study, glass transition temperature, vapor pressure estimation, hygroscopic study by DSC, TGA and DVS. Reviewing method validation Protocol and method transfer study. Reviewing method validation Report and method transfer report. Setup new technical support lab for supporting release of all the technical batches samples In charge of Instrument qualification, calibration, specification preparation, SOP/IOP preparation, PSSR, QMS, Audit CAPA and other compliance issue. Computer system validation for quality instruments. Responsible for client Audit, USFDA, ISO and other regulatory audits Routine release of manufacturing batches within the target without deviation Responding Regulatory query and investigating regulatory complaints and suggesting to regulatory query. Conducting feasibility study and method verification study for compendial methods. Involving Qualification of Instruments (IQ, OQ and PQ) and calibration of the HPLC, GC-HS and others. Troubleshooting of Instrument and analytical method. Responding to client comments and facing the audit. Costing sheet preparation for existing and new proposal