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Mahesh Kulkarni

Founder And CEO

About Mahesh Kulkarni


Mahesh Kulkarni is the CEO of QualiCulture Consulting Group (QCG) and provides leadership, direction and management of the QCG consulting operations. Mr. Mahesh founded QCG after a 25-year career in the pharmaceutical, biologic and biotechnology industries, where he held significant positions of responsibility for Quality, GxP Compliance, Regulatory Affairs, Technology Transfer and Technical Operations functions of Injectable, Medical Devices and Biological/Vaccines Industries in India and abroad. Mr. Mahesh delivers the strategic guidance and direction in Quality and GxP Compliance projects, which includes establishment of controls through assessment, analysis, planning and implementation of sustainable solutions.
EXPERTISE:      

  • Deliver regulatory, compliance, science and technology expertise and oversight
  • Lead resolution of compliance issues - Regulatory Findings and Enforcement Actions in his last two organizations
  • Participated in face to face meetings with US FDA and WHO senior officials to state the company's position in addressing the compliance issues
  • Serve as Subject Matter Expert on Quality, GxP Compliance,  Microbiology and Sterility Assurance
  • Provide expertise in the establishment of processes to address senior management responsibility for compliance and quality in GxP areas
  • Establishment of Quality Function and Quality Leadership Development
  • Coordinate corporate integrity agreement compliance, application integrity policy audits, technology transfer, due diligence, and product and company acquisitions
  • Oversee and Manage Regulatory inspections -  Inspection and SME Readiness
  • Provide advice to Senior Executives at Client Firms 
  • Develop / implement Global Quality Systems strategies
  • Deliver remediation of international regulatory enforcement action remediation expertise 
  • Lead product quality assessments and data integrity assessments 
  • Provide training on Quality and Compliance issues

EXPERIENCE:        

  • Vice President - Global Quality Management at Dr.Reddy's Laboratories Ltd. 
  • Senior Vice President - Head of Quality at Hospira Healthcare India Private Ltd.
  • Senior Vice President - Head of Technical Operations, Quality and Regulatory Affairs  at Biological E. Ltd.
  • Worked in USA and Europe for   companies like Baxter, Strides Arco, Fresenius Kabi and Johnson and Johnson in the Head Roles in Quality, Compliance, Operations and Technology Transfer.

EDUCATION:        

  • Master of Science in Microbiology
  • Post Graduate Diploma in Quality Management

PROFESSIONAL AFFILIATIONS:        

  • Working as an Expert in Parenteral products to Indian Pharmacopoeia Commission
  • Associate member of IMDRA 
  • Empanelled  for Indian NRA Inspectors (DCGI/CDSCO) on “Risk based Inspections”


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