Hire Kushagra Gupta, a pharma consultant specializing in FDA Inspections, 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: Kushagra Gupta is a pharmaceutical manufacturing excellence consultant specializing in quality management systems, GMP compliance, FDA inspection readiness, and equipment qualification. His expertise also includes GMP audits, deviation investigations, regulatory response writing, warning letter remediation support, and GMP training. His career includes experience with Intas Pharmaceuticals, Mylan Laboratories, Wockhardt, and Mankind Pharma, alongside quality and validation consulting at Reveon.AI. He supports sterile, injectable, and oral solid dosage facilities through compliance gap assessments, documentation improvements, shop-floor monitoring, and corrective action planning. His consulting approach combines practical manufacturing oversight, quality metrics, employee coaching, and ongoing compliance monitoring to help organizations strengthen quality systems and maintain inspection readiness. - Show More
Kushagra supports deviation investigations through investigation review, root cause analysis, quality risk assessment, and CAPA planning. His experience also covers OOS/OOT events and quality system trending. He helps teams assess investigation evidence, improve the clarity of reports, and develop corrective actions aimed at addressing underlying causes and reducing recurring issues.
Kushagra supports equipment qualification through user requirement specifications, design qualification, installation qualification, operational qualification, and performance qualification. His expertise includes sterile manufacturing equipment such as steam sterilizers, depyrogenation tunnels, vial washers, lyophilizers, laminar airflow units, and filter integrity testers. He helps engineering and validation teams establish clear qualification documentation and assess equipment readiness.
Kushagra supports FDA inspection readiness through plant assessments, compliance gap reviews, documentation improvements, and monitoring of corrective actions. His consulting approach includes evaluating manufacturing practices, strengthening quality systems, and preparing teams for inspection expectations. He helps facilities maintain readiness through regular oversight of operations and quality records.
Kushagra supports FDA warning letter response writing and remediation planning through assessment of quality system and manufacturing compliance gaps. His approach includes root cause analysis, documentation improvements, and corrective action planning. He helps organizations develop structured responses and establish ongoing monitoring to assess the implementation and sustainability of remediation measures.
Kushagra supports preparation of FDA-483 responses and associated remediation plans. His services combine regulatory response writing with review of investigations, supporting documentation, and proposed corrective actions. He helps teams organize responses to inspection observations, identify relevant evidence, and track remediation activities through their quality management systems.
Kushagra conducts internal GMP audits and compliance gap assessments for pharmaceutical manufacturing facilities. His services include reviewing quality systems, shop-floor practices, and supporting documentation, alongside vendor qualification support. He helps organizations identify deficiencies, prioritize improvement actions, and integrate audit findings into ongoing quality monitoring and management reviews.
Kushagra supports GMP compliance through ongoing shop-floor monitoring, documentation review, and quality improvement activities. His work includes reviewing master production records, SOPs, batch records, and logbooks, with attention to data integrity and consistent execution. He helps manufacturing teams identify gaps in routine practices and implement improvements supported by employee coaching and continued monitoring.
Kushagra provides training and coaching on current GMP, pharmaceutical quality systems, data integrity, regulatory expectations, and equipment qualification. His experience includes guest lectures at PSIT Kanpur and employee coaching within his consulting approach. He helps teams connect compliance requirements with daily manufacturing practices, documentation responsibilities, and quality system procedures.
Kushagra supports pharmaceutical quality management systems through assessments, gap identification, SOP development, and system improvements. His experience covers deviations, CAPA, OOS/OOT, change control, quality risk assessments, and annual product quality reviews. He helps teams strengthen quality processes, develop meaningful quality metrics, and use management reviews to monitor performance and follow-up actions.
