Umesh Ahire

About Umesh Ahire

I have 14 years experience in Production. Sound knowledge of QMS, Audit compliance…

Experience

1. Production Manager

   Garonit Pharmaceutical

   Mar 2025 — Present · Surat, IN

   Production Planning & ExecutionPrepare and implement daily, weekly, and monthly production plans in line with market demand and inventory targets.Coordinate with SCM (Supply Chain Management) to ensure timely availability of raw materials and utilities.2. Process Optimization & Technical OversightMonitor critical process parameters (CPPs) and critical quality attributes (CQAs).Drive yield improvement, cycle time reduction, and cost optimization initiatives.Support scale-up, validation, and technology transfer activities from R&D.3. Quality & Regulatory ComplianceEnsure strict adherence to cGMP, ICH, USFDA, EUGMP, WHO-GMP, and other regulatory standards.Review and approve BMRs, BPRs, SOPs, change controls, and deviation reports.Face regulatory audits and prepare responses for observations (e.g, CAPA, OOS, OOT).4. People ManagementManage and develop production teams, including supervisors, operators, and technicians.Conduct training sessions on SOPs, EHS, cGMP, and best practices.Maintain high morale, discipline, and operational accountability within the team.5. Operational Efficiency & SafetyMonitor utility consumption (steam, water, power) and promote energy-efficient practices.Lead root cause analysis (RCA) for breakdowns or deviations and implement corrective actions.Ensure strict implementation of EHS (Environment, Health & Safety) norms including handling of hazardous chemicals.6. Cross-Functional CoordinationCollaborate closely with QA/QC, Engineering, Maintenance, Warehouse, and R&D departments.Participate in cross-functional project teams for new product introduction and facility expansion.7. Documentation & ReportingEnsure timely documentation and logbook maintenance as per GDP (Good Documentation Practices).Provide regular production MIS, KPI dashboards, and reports to senior management.

Education

• Jaihind College Dhule

  Master of Science (M.Sc.), Organic Chemistry

• BSSPM'S Arts and Science College Songir

  Bachelor of Science (B.Sc.), Chemistry

  2005 — 2009

Skills

• Batch Production Record
• Standard Operating Procedure (Sop)
• Isrs
• Sap
• Pharmaceutical Industry
• Centrifuge
• Microsoft Word
• Production Documentation
• Man Power
• Validation
• Hazop Study
• Reactor
• Process Control
• Vtd
• Scada
• Quality Assurance
• Drying
• Environment, Health, and Safety (Ehs)
• Cgmp Manufacturing
• Internal Audit
• Gmp
• Api Manufacturing
• Regulatory Audits Faced
• Process Monitoring
• On the Job Training
• Document Review
• Fire Fighter
• Troubleshooting
• Micronizer
• Corrective and Preventive Action (Capa)
• Batch Production Record
• Change Control
• Equipment Handling
• Filtration
• Material Requirements Planning (Mrp)
• Api Packing
• Microsoft Excel