Igor Udod Email & Phone Number

• Managed all aspects of QC/RD laboratory operations, with responsibilities for new USP/ICH method remediation and changes implementation (ICH Q3B (organic impurity), USP<467>, ICH Q3C (residual solvents), ICH Q3D, USP <232>, <233> (elemental impurities) • Experience in Analytical part of ANDA submission (QOS, Development reports, MV reports etc.)• Strong Familiarity with CAPA, Change Controls, and OOS investigation systems (LIMS, Trackwise)• Recently developed Quality Services Laboratory operations responsible for sophisticated forensic services (non-destructive complain sample, counterfeit investigations, or different production issues) and also ICP-MS, ICP-OES testing • Developed Method Validation and Training Program for Raman RM ID technology implementation in Pharmaceutical Industry.• GC, HPLC, UPLC, LC/GC-MS, ICP-MS, XRF, SEM, TEM, AA, XRD, TGA, DTA, DSC, UV-, FTIR-, NIR-, Raman- and NMR experience, • Document Management Systems: GxPharma, Wisdom, QDocs, MasterControl, Trackwise, LIMS.• USP, EP, JP, GLP/GMP, FDA and ICH guidelines

Listed skills include Analytical Chemistry, Pharmaceutical Industry, Chemistry, Hplc, and 38 others.