Hire Jayant K Indane, a pharma consultant specializing in Analytical Testing, FDA Inspections, Medical Devices 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: Jayant K Indane is an experienced pharmaceutical Quality Control and Quality Assurance professional with over 27 years of expertise across Quality Control, Quality Management System, GMP Audit, GMP Compliance, Supplier Qualification, Method Validation, Regulatory Filing, FDA Inspection Readiness, and FDA-483 Response and Remediation. His experience spans raw materials, packaging materials, APIs, oral and sterile dosage forms, analytical laboratories, and pharmaceutical manufacturing operations. He has led QC teams, managed OOS/OOT/OOC investigations, CAPA, change controls, data integrity assessments, supplier audits, analytical method transfers, qualification and validation activities, and regulatory inspection preparedness. Jayant has supported more than 40 regulatory inspections involving USFDA, MHRA, WHO, TGA, ANVISA, and EU GMP authorities and has experience handling inspection observations, 483s, regulatory remediation, ANDA/DMF documentation, and other regulatory challenges. - Show More
Jayant has extensive experience preparing pharmaceutical organizations and Quality Control laboratories for USFDA and other international regulatory inspections. His experience includes inspection readiness, gap assessment, regulatory response preparation, quality-system review, remediation planning, and management of inspection observations. He has participated in numerous USFDA inspections and successfully supported a USFDA audit that concluded without Form 483 observations.
Jayant has direct experience handling FDA 483 observations, inspectional findings, GMP deficiencies, and associated remediation activities. His background includes investigation of compliance gaps, preparation and review of regulatory responses, CAPA development, quality-system remediation, and follow-up actions designed to address root causes and strengthen sustainable compliance.
Jayant has significant experience with internal audits, supplier audits, quality-system audits, and regulatory inspection preparation across pharmaceutical manufacturing and laboratory environments. His background includes auditing manufacturing, packaging, facilities, engineering, material management, Quality Control, contract laboratories, and external suppliers. He can support organizations with GMP gap assessments, audit preparation, compliance evaluation, and development of practical remediation actions.
Jayant has strong hands-on experience in analytical method development, validation, transfer, troubleshooting, and pharmaceutical laboratory operations. His background includes analytical method transfer to customer and EU sites, validation protocols, specifications, test methods, stability testing, instrument qualification, and regulatory documentation. He can support organizations with analytical method validation, transfer activities, laboratory documentation, troubleshooting, and implementation of compliant analytical procedures.
Jayant has extensive experience leading pharmaceutical Quality Control operations across raw materials, packaging materials, APIs, oral dosage forms, sterile products, stability, GLP, and microbiology laboratories. His responsibilities have included laboratory testing oversight, analytical troubleshooting, specifications and test methods, laboratory documentation, investigations, regulatory compliance, and management of large QC teams. He can support pharmaceutical organizations in strengthening laboratory operations, analytical quality, documentation practices, and overall QC performance.
Jayant has strong expertise in the implementation, improvement, and remediation of pharmaceutical Quality Management Systems. His experience covers deviations, OOS/OOT/OOC, CAPA, change management, investigations, market complaints, vendor management, quality metrics, SOPs, risk assessments, and continuous improvement. He can support organizations in identifying QMS gaps, strengthening governance and documentation, improving investigation systems, and maintaining sustainable regulatory compliance.
Jayant has extensive supplier and vendor quality experience covering raw materials, packaging materials, drug substances, drug products, and contract testing laboratories. His work has included supplier audits, vendor management, technical and commercial discussions, quality agreements, compliance assessments, and ongoing oversight. He can support pharmaceutical organizations in evaluating supplier quality systems, identifying compliance risks, and strengthening supplier qualification and monitoring processes.
