• Assisted the Manager with Drug Product Development as per Innovator Specifications.• Conducted the Literature survey on NDA drug products from USFDA, Health Canada, EMC, PMDA,• Prepared and Performed the Analytical Method Validation and Verification of Drug substances of 04 molecules.• Prepared and Performed the Comparative Dissolution Profile of one drug Product.• Prepared the Analytical Testing Method of Drug Substances and Stability Products, IN House, USP, BP, JP.• Prepared the Monthly Stability Planned and conducted the Stability studies.• Assisted the Manager R&D in Self Inspection to ensure PQMS compliance.• Assisted the Manager for prepare the CTD Dossier file and full fill the regulatory requirement

• Participated in the implementation of QMS in R&D and QC Laboratory as per the Requirement of ISO/lEC-17025.• Assisted the supervisor for approved the Generic Drug Product from Regulatory Bodies.• Performed the API, New drug Development product, trial batches, stability studies and maintain their records.• Performed AMV, DMV, PMV, and CDP Dissolution Method Development, in accordance with pharmacopeia guidelines.• Performed Force degradation studies of molecules to ensure your method is stability indicating method.• Performed Proficiency test (PT) for ISO-17025• Reviewed and investigate the OOT/OOS results.• Ensured that data integrity is maintained as per ALCOA principle.• Hardware and Software troubleshooting of laboratory instruments.• Ensured on-time preventive maintenance and calibration/verification of assigned analytical equipment and maintained their record.• Prepared the Technology transfer protocol in collaboration with QC and Validation.

Research and Development department