Rameshwar Nalawade

Background

About Rameshwar Nalawade

Experience of more than 21 years in Analytical Development Analytical method development, method validation study of NCE’s and different types of formulations. Conversant with anlytical method development, method validation and writing reports as per various (USFDA, UK-MHRA,ICH) guidelines. Setting up of laboratory and advanced instruments. Expertise handling of various sophisticated instruments used HPLC, UPLC,GC, GPC, UV spectrophotometers, FTIR, Dissolution apparatus(USP I,II and Atomic absorption spectrophotometer, Particle size analyzer, Liquid particle analyzer, Autotitrator, DSC, Karl Fischer, Water activity meter and etc. as per and cGMP standards. Designed and performed experiments based on cGMP, cGLP, ICH, and FDA regulations. Troubleshoot results and perform root cause analysis. Investigate laboratory out of specification [OOS] test results and documents findings. Technical transfer: Involved in strategies for technical transfer of analytical methods from R&D to plant. Stability studies- as per ICH guidelines. Stability extrapolations, prediction of self life calculations.(Sample Management, Scheduling, analysis, documentation and data generation). Write technical reports and prepares data for presentation and review. Create SOP’s, test procedures, change controls and reports. Cleaning validation - worked under guidance of consultants / superiors for compliance of the international regulatory requirements. Worked in ANDA analytical laboratory and handled ANDA project. Worked Continuous manufacturing projects.