Dinesh Bagde
Pharma Engineering Professional | Maintenance, Projects & QMS Expert | 12+ Years Experience | Lean Six Sigma Black Belt Certified | ISO 9001:2015 Lead Auditor certified.
- Role
- Executive Engineer at Ajanta Pharma Ltd
- Location
- Nagpur, MH, IN
- LinkedIn followers
- 500 followers
About Dinesh Bagde
12+ years of experience in pharmaceutical plant engineering, maintenance, utilities, and QMS in a GMP environment.Preparation, review, and control of SOPs; handling Change Control, Deviations, Incidents, CAPA, Investigations, and Risk Assessments with timely closures.Management of QMS documentation using QMS, DCS, e-Log, DRS, and TRIMS software.Preparation and closure of internal, external, regulatory, and vendor audit responses.SOP harmonization across multiple sites and participation in QMR meetings.Handling training management including TNI, training schedules, PPT preparation, execution, and effectiveness monitoring.Preparation and execution of equipment and utility qualifications (URS, DQ, IQ, OQ) and requalification activities.Handling compressed air testing, trending reports, technical agreements, and compliance documentation.Planning and execution of instrument calibration, weighing balance calibration, and management of AMC contracts.Strong exposure to safety systems: work permits, fire protection systems, pressure vessels, lifting devices, and statutory compliance.Operation and maintenance of utilities: AHUs, air compressors, boilers, chillers, purified water systems, dust collectors, vacuum pumps, and ETP.Maintenance of manufacturing equipment: granulation, compression, coating, inspection, and packing machines.Execution and monitoring of preventive maintenance with software-based tracking.Management of critical spares, vendor coordination, PR creation, and cost control.Active involvement in internal/self-inspections, external audits, and compliance closures.
Experience
Executive Engineer
Jun 2024 — Present · Paithan, IN
Handling QMS documentation. SOP\'s, Change Control, Deviations, incidents, CAPA, RCA, Risk Assessment, Internal audits, External Audits, Training, Qualification, validation, Calibration. Working on Caliber QMS, DMS, Caliber e-Log, TRIMS, DRS.
Education
Nagpur Institute of Technology, Nagpur
Nagpur Institute of Technology, Nagpur, Mechanical Engineering
2009 — 2013
S.B.jain Institute of management and Research
Master of Business Administration (MBA), Marketing maagement and Human Resources Management
2014 — 2016
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