Prashant Karamkar

WORK HISTORY

EDUCATION

ABOUT PRASHANT KARAMKAR

Project activity for OSD Formulation R&D set-up, Negotiation on price & purchase of Machines & Instruments, FAT, SAT, IQ,OQ,PQ, execution of ACA, CDA and Quality Agreement with vendors, Evaluation of project feasibility and cost considering FTE. Pre-formulation, Development and Scale-up at plant of oral solid dosage (OSD)/Harmone and liquid oral dosage forms for Regulated and emerging markets with analytical skill. Responsible for process optimization, scale-up, provide technical support for manufacturing and Troubleshooting of commercial products, Closely work on team development, project tracking by communication with related departments like RA, IPR, QA, Store, Purchase, TT, QC, Production, Liaison, ADL. Addressing post submission queries of different regulatory agencies, Developed ER, Controlled release, Modified release tablets and capsules, pellets, IR tablets; Liquid orals, QbD based product with DoE approach. Successfully developed formulations of BCS Class I -IV, worked on Para F2F, II, IV and NCE-1 filling. Designing of Patent non-infringing strategies. Review & praparation of R&D documents (MFR, BMR, TTD, Process Validation report, PDR) for regulatory submission. Preparation of SOP & implementation. Sound knowledge of use of PAT Tools in product development. Sound knowledge of Microsoft Excel, word, PowerPoint, LIMS, SAP.