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Neeraj Jayant Khare

Senior Associate

About Neeraj Jayant Khare

Neeraj Khare is a Senior Associate in the GMP Compliance Practice at QualiCulture Consulting Group, who has over 20 years of experience. His approach is to determine and implement the proper technical and quality strategy for the situation at hand. He is experienced in various dosage forms including sterile and non-sterile. He is an accomplished team leader in internal and supplier quality auditing. He is experienced in interactions with the US FDA, EU and other worldwide regulatory agencies inspections. He has guided the teams in implementation of internal quality standards leading to successful regulatory inspection. 

  • Provide QA oversight for aseptic manufacturing and filling operations and implementing global processes
  • Review batch records and determine product dispositions for aseptic bulks, raw materials, blends, and finished goods
  • Conduct audits of Quality Systems to assure compliance with internal SOPs, standards and regulatory requirements
  • Perform quality reviews of sterilization and aseptic validation and revalidation protocols, including media fills
  • Conduct investigations into process deviations and problems, and determine appropriate corrective and preventive actions to prevent recurrences, including laboratory and positive sterility investigations
  • Review QA audit reports for compliance with internal quality standards and SOPs; identify corrective and preventive actions to remediate non-conformances noted during audits
  • Develop internal and supplier quality audit programs and schedules
  • Participate in US FDA, EU and other worldwide regulatory agency pharmaceutical inspections as subject matter expert; manage teams to support record / information requests during regulatory inspections
  • Develop procedures and specifications for new products
  • Develop and deliver GMP training programs
  • Developed strategic protocol for over-arching review of remediation activities along with identifying involved personnel, system gaps and implementing effective CAPAs
  • Lead product quality assessments and data integrity assessments
  • Lead Qualification/ Validation Assurance teams, which includes review of activities associated with IQ/OQ/PQ of Equipment and critical utilities
  • Provided Technical leadership for global harmonization of quality systems 


  • Worked as General Manager and Head Quality Assurance at World's larget Multinational Pharmaceutical Company 
  • Associate Director - Head Regulatory Compliance in Global Quality Management at Dr.Reddy's Laboratories Ltd. 
  • Worked at Emcure Pharmaceutical Ltd in various roles related to Quality Control and Quality Assurance functions at site and corporate level.


  • Graduation in Pharmacy

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