Hire Karthikeya K M T, a pharma consultant specializing in FDA Inspections, Pharmaceutical Manufacturing, Pharmaceutical Quality and Sterile Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Karthikeya K M T is an accomplished pharmaceutical and biotechnology Quality and Technical Operations professional with over 27 years of experience across GMP Audit, Third Party GMP Audit, GMP Compliance, Quality Management System, Supplier Qualification, Equipment Qualification, Process Validation, Cleaning Validation, and Sterility Assurance. His experience spans oral solid and liquid dosage forms, parenterals, biological products, vaccines, therapeutic proteins, plasma derivatives, and complex pharmaceutical manufacturing operations. He has led and supported numerous global regulatory inspections and brings extensive experience in greenfield and brownfield projects, commissioning and qualification, remediation, contamination control, technology transfer, data integrity, vendor auditing, and inspection readiness. His combination of senior quality leadership, validation expertise, sterile manufacturing knowledge, and global regulatory exposure enables him to support pharmaceutical organizations in establishing sustainable, inspection-ready, and compliant manufacturing systems. - Show More
Karthikeya has extensive experience developing and harmonizing cleaning-validation programs using science- and risk-based approaches. His work includes cleaning-validation lifecycle management and the development of strategies using Permitted Daily Exposure toxicological limits for multi-product pharmaceutical manufacturing facilities.
Karthikeya has extensive experience in commissioning, qualification, and lifecycle management of pharmaceutical manufacturing equipment, laboratory systems, utilities, automated systems, and associated infrastructure. He has developed and implemented risk-based CQV strategies and qualification frameworks for both greenfield and brownfield pharmaceutical projects.
Karthikeya supports pharmaceutical and biotechnology organizations in preparing for USFDA inspections through gap assessments, remediation planning, quality-system strengthening, data-integrity controls, and inspection-readiness programs. His experience includes participation in numerous global regulatory inspections and multiple USFDA remediation projects involving data integrity, technical systems, and process remediation.
Karthikeya provides GMP audit and compliance-assessment support across pharmaceutical manufacturing operations. His consulting work includes GMP gap assessments, evaluation of quality systems, inspection preparedness, and development of practical remediation roadmaps to address compliance risks and improve sustainable GMP performance.
Karthikeya has extensive experience establishing and maintaining GMP-compliant systems across pharmaceutical and biotechnology operations. He supports organizations with quality governance, regulatory compliance, remediation, data integrity, risk management, and implementation of systems aligned with global regulatory expectations.
Karthikeya supports pharmaceutical organizations with process-validation strategy, execution, lifecycle management, and risk-based validation approaches. His experience includes validation governance, new product introduction, technology transfer, commercial manufacturing readiness, and maintaining validated processes across regulated manufacturing environments.
Karthikeya has strong expertise in the design, implementation, remediation, and continuous improvement of pharmaceutical Quality Management Systems. His experience covers deviations, CAPA, change management, investigations, quality risk management, documentation, training, data integrity, management review, and electronic QMS platforms.
Karthikeya brings extensive sterile-manufacturing and contamination-control experience covering aseptic techniques, environmental monitoring, media-fill studies, sterilization processes, operator qualification, material-transfer systems, and contamination-control strategies. He can support organizations in developing robust sterility-assurance programs and maintaining regulatory readiness for sterile pharmaceutical operations.
Karthikeya provides supplier qualification and vendor-quality support through extensive experience with risk-based supplier assessment, GMP auditing, lifecycle management, Quality Technical Agreements, and external partner oversight. He has participated in more than 80 vendor audits covering FDF manufacturers, APIs, packaging materials, laboratories, distributors, and service providers.
