Hire Prabaharan Gurusamy, a pharma consultant specializing in FDA Inspections, Medical Devices, Pharmaceutical Manufacturing and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Prabaharan Gurusamy is an experienced pharmaceutical Quality professional with over 19 years of industry experience across Quality Management System, GMP Compliance, Quality Assurance, Supplier Qualification, Process Validation, Cleaning Validation, Equipment Qualification, and FDA Inspection Readiness. Currently serving as Head of Quality, he has led both QA and QC functions and has extensive experience implementing and maintaining robust quality systems aligned with cGMP, ICH, USFDA, and PIC/S expectations. His background includes regulatory inspections, vendor qualification, deviations, CAPA, OOS investigations, change controls, data integrity, technology transfer, validation and qualification programs, regulatory documentation including CEPs and DMFs, and API manufacturing quality systems. He also brings experience in project commissioning, automated quality systems, ERP/LIMS implementation, and leading cross-functional quality teams. - Show More
Prabaharan has direct experience with cleaning-validation systems within API manufacturing operations. His quality and validation background enables him to support cleaning-validation strategy, documentation, execution oversight, review of compliance requirements, and identification of gaps affecting contamination control and manufacturing quality.
Prabaharan has experience with equipment qualification and validation activities, including project commissioning and qualification of manufacturing systems. His background also includes water-system validation and quality oversight of qualification activities, enabling him to support organizations in establishing GMP-compliant qualification programs for manufacturing equipment and associated systems.
Prabaharan has strong regulatory-inspection experience and has played a key role in successful USFDA audit responses. His experience across QMS, GMP compliance, data integrity, validation, CAPA, investigations, regulatory documentation, and audit-observation closure enables him to support pharmaceutical organizations in preparing for USFDA inspections, identifying readiness gaps, and strengthening quality systems before regulatory review.
Prabaharan has strong experience ensuring pharmaceutical operations remain compliant with cGMP, ICH, USFDA, and PIC/S requirements. His background covers quality-system implementation, manufacturing compliance, regulatory inspections, data integrity, validation, risk management, and regulatory response activities. He can support pharmaceutical organizations in assessing GMP gaps, improving compliance practices, and maintaining regulatory readiness.
Prabaharan has substantial experience with process validation in API manufacturing environments. His responsibilities include validation strategy, execution oversight, regulatory compliance, risk assessment, documentation review, and coordination with manufacturing and technical teams. He can support organizations in establishing and maintaining robust process-validation programs aligned with GMP expectations.
As Head of Quality, Prabaharan leads Quality Assurance operations and has extensive experience in QMS governance, deviations, CAPA, change control, investigations, validation oversight, documentation, data integrity, and regulatory compliance. He can assist organizations in strengthening QA systems, improving documentation and investigation practices, and ensuring effective quality oversight across pharmaceutical manufacturing operations.
Prabaharan also leads Quality Control functions and brings significant experience managing QC activities within API and regulated manufacturing environments. His background includes OOS investigations, data integrity, laboratory quality systems, LIMS implementation, regulatory inspection support, and cross-functional coordination between QA and QC. He can support organizations in improving QC governance, laboratory compliance, investigation practices, and overall analytical quality operations.
Prabaharan has extensive experience implementing, monitoring, and strengthening pharmaceutical Quality Management Systems within API and regulated manufacturing environments. His hands-on responsibilities include deviations, CAPA, OOS investigations, change controls, data integrity, risk assessment, and timely closure of critical quality-system issues. He can support organizations in evaluating QMS effectiveness, identifying compliance gaps, strengthening governance, and building sustainable quality systems aligned with global regulatory expectations.
Prabaharan has direct hands-on experience in vendor qualification as part of pharmaceutical quality operations. His background enables him to support supplier evaluation, compliance assessment, risk-based qualification, documentation review, and ongoing oversight of external vendors supporting pharmaceutical manufacturing and quality operations.
