Nitten Musale

Director @Inveax Global Consulting & Exportss

Indore, IN

Project & Process Consultancy, Recruitment, GMP Documentation, Pre audits & Exports.• Achieved a cost saving of ₹10 Cr at Glenmark for FY 20••••20 through cost-saving projects. • Specializing in Operations, Process consultancy, Process Optimization, Documentation and Technology Transfers for Topical Aerosols, Inhalers (pMDI, DPI, Nasal Spray), OSD, Liquids, Semisolids, Injectables.• cGMP Documentation: o Preparation of concept note, project report.o Preparation / review of User Requirement Specifications (URS).o Manage procurement of new machinery, including Factory Acceptance Testing (FAT), Site Acceptance Test (SAT), Risk Assessment (RA) and equipment qualifications DQ, IQ, OQ, PQ.o Preparation / review of Standard Operating Procedures (SOPs)o Preparation / review of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)• Plant Layout Review : o To ensure compliance with EU, MHRA, USFDA and other regulatory requirements and cost savings. • Automation projects• Technology Transfer• Internal Audits, Gap Analysis:o Conduct internal audits and gap analyses to ensure practices and documentation meet regulatory standards.• Operational Excellence & Cost Optimization:o Implemente strategies for Overall Equipment Effectiveness (OEE) improvement, yield enhancement, capacity expansion, batch cycle time reduction, changeover time reduction, cost reduction, and manpower savings.• Manpower Recruitment & Trainings• Exports

Pravara Rural College Of Pharmacy, Pravaranagar

B. Pharma

Pravara Rural Education Society's College of Pharmacy

Bachelor's degree

Institute of Pharmacy, Dhule

D. Pharma