Rohit Dhande

About Rohit Dhande

With a master\'s in pharmacy and over 14.3 years of extensive experience in formulation…

Experience

1. Manager

   Viatris

   Jul 2015 — Present · Chhatrapati Sambhajinagar, IN

   A results-driven pharmaceutical professional with comprehensive experience in Process Performance Qualification activity,Batch Manufacturing Record (BMR) preparation, review and approval with the help of D2 Documentum system, and scale-upoptimization within regulated environments (cGMP, FDA, MHRA, etc.). Skilled in designing and executing validation protocols(IQ/OQ/PQ/PPQ), ensuring manufacturing processes consistently produce quality productsPossesses a strong understanding of product lifecycle management from development to commercial scale, includingtechnology transfer, process qualification, and continuous process verification. Adept at collaborating with cross-functionalteams including R&D, Quality Assurance, and Production to ensure smooth scale-up from lab/pilot to commercial batches,with a focus on cost-efficiency, quality compliance, and productivity.Key Responsibilities:Preparation, review, and approval of BMRs and process-related documents as per GMP and regulatory requirements.Execution and documentation of process validation and cleaning validation activities.Participation in scale-up and technology transfer activities from R&D to production.Optimization of manufacturing processes to improve yield, reduce variability, and ensure robustness.Investigation and resolution of process deviations and implementation of CAPA.Coordination with QA/QC for timely approvals and release of batches.Core Competencies:Process Validation (PPQ, Continued Process Verification)BMR Preparation, Review & ApprovalScale-up & Technology TransfercGMP Compliance & Regulatory AuditsProcess Optimization & TroubleshootingRisk Assessment & Quality by Design (QbD)Cross-functional Team Collaboration

Education

• North Maharashtra University, Jalgaon

  M.PHARM

  2008 — 2010

• North Maharashtra University, Jalgaon

  Bachelor of Pharmacy (B.Pharm.)

  2008