Hire Krishnakant Vichare, a pharma consultant specializing in 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: Krishnakant Vichare is an experienced pharmaceutical Quality Operations Leader and Consultant with more than 30 years of industry experience, including over two decades in QA and QC leadership roles across API manufacturing facilities and analytical CROs. His expertise includes Quality Management Systems, regulatory compliance, scientific investigations, deviations, OOS/OOT investigations, CAPA, data integrity, validation, vendor qualification, and pharmaceutical auditing. He has supported regulatory readiness for international standards including USFDA and MHRA requirements and has conducted more than 100 audits across API, formulation, excipient, KSM, and CRO facilities. His experience also includes reviewing process and method validation activities, cleaning validation limits, technical documentation, and complex quality investigations, enabling him to support pharmaceutical organizations with practical quality-system remediation and compliance improvement. - Show More
Krishnakant provides cleaning validation support for pharmaceutical manufacturing operations, including the review of cleaning-validation strategies, documentation, and scientifically justified Maximum Allowable Carryover (MACO) limits. His strong QA/QC and analytical background enables him to assess potential carryover and contamination risks and support organizations in maintaining effective, scientifically defensible cleaning controls.
Krishnakant supports pharmaceutical organizations with the investigation and resolution of deviations and other complex quality events. His experience includes root-cause analysis, risk and impact assessments, OOS/OOT investigations, scientific technical write-ups, and CAPA development. He helps organizations strengthen investigation quality, identify underlying causes, develop appropriate corrective actions, and produce documentation capable of supporting regulatory scrutiny.
Krishnakant provides support for the review and assessment of pharmaceutical process validation activities. His experience includes reviewing and approving process-validation protocols, technical-transfer documentation, and related quality records. Drawing on extensive experience in API manufacturing and QA/QC leadership, he can help identify validation gaps and strengthen the scientific rationale, documentation, and compliance of validated manufacturing processes.
Krishnakant has extensive experience establishing, evaluating, maintaining, and remediating pharmaceutical Quality Management Systems. He has reviewed hundreds of QMS records covering deviations, OOS/OOT investigations, incidents, change controls, and CAPA activities. He supports organizations in strengthening quality-system effectiveness, improving documentation, addressing compliance gaps, and maintaining readiness for regulatory inspections and audits.
Krishnakant provides supplier and vendor qualification support through technical audits and quality-system assessments. His auditing experience spans API facilities, formulation plants, KSM manufacturers, excipient suppliers, and CROs. He can assist pharmaceutical organizations with evaluating supplier compliance, identifying quality and operational risks, reviewing quality systems, and maintaining effective oversight of external manufacturers, suppliers, and service providers.
Krishnakant offers independent third-party GMP auditing services for pharmaceutical organizations requiring experienced external audit support. Having conducted more than 100 audits across pharmaceutical manufacturing facilities and CRO networks, he can evaluate GMP systems, manufacturing practices, documentation, data integrity, laboratory operations, and regulatory compliance. His extensive QA/QC leadership and regulatory readiness experience enables him to identify significant compliance gaps and provide practical recommendations for remediation and inspection preparedness.
