Dr. Hemant Tawale (PDF-USA)PhD,M.Pharm,PGDIPL,FIAST,LSS,(PMP)'s Linkedin Analytics

Analytical Research Formulations:  Method Development for Dissolution by UPLC/HPLC & Assay, CU, BU & RS by HPLC of Different OSD formulations such as Tablets, Capsules, Pellets & Liquid Orals for US/Europe:  Literature search related to the drug substance, create analytical profiles.  Develop analytical method for drug substance and their drug product.  To perform and conduct analysis of development samples as received from formulator and provide them with analytical report in the defined timeline.  To conduct calibration of allotted equipment with proper documentation and maintain the equipment in good condition. To follow the SOP of usage and document in the logbooks.  To perform and conduct analysis of stability samples and prepare stability reports.  To validate the method developed and prepare validation report.  Preparation and Review of Development Protocols, Method Development Reports, STP’s & Specification’s, Validation Protocols and reports.  Maintain lab notebooks in proper condition and keep it updated at all times.  Method Development for Viscosity by Viscometer, Particle, Globule size, Crystallinity by Microscopy & Assay, RS by HPLC of Different Semisolid formulations such as Ointment, Cream, Paste, Gel & Lotion for US/Europe market:  Perform Lab to lab or Technology transfer of analytical method to the transferring site.  Prepare documents related to tech transfer for commercial transfer of the method.  Maintain lab notebooks in proper condition and keep it updated at all times.  For CQA internal audit: Review LNB’s and Analytical data with relevant documents which are required for audit.  Report Preparation and Review the Monthly Project audit trial record of Empower and submitted to DQA within timeline for all products.  Development and Reviewer activity for Elemental Impurities analysis of all Glenmark Finished Products Semisolids /OSD, Excipients, API’s by ICP-MS for US & EU market:  Development & Validation of Elemental impurities method as per ICH Q3D guidelines.  Strong review of Method Development and Validation raw data & analytical system data required for preparation & compilation of report and STP’s & Specifications.  Handling LER & Incident Initiation with CAPA activities for both ICP-MS & MDS instruments.  Completion of FDA Deficiency of elemental impurities in API, Excipients and formulations.  Internal co-ordination with CFT as F&D, DQA, PDL, Plant-QC, QA, PM and to resolve the queries.