Hire Adish Bhatnagar, a pharma consultant specializing in 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: Adish Bhatnagar is a Certified Lead GxP Auditor and pharmaceutical consultant with extensive experience across GMP Audit, Third Party GMP Audit, Supplier Qualification, Quality Management System, GMP Compliance, and GMP Training. He has conducted more than 420 remote and on-site audits covering API manufacturers, finished pharmaceutical products, excipients, key starting materials, intermediates, packaging materials, medical devices, transporters, distributors, and clinical-related facilities across multiple international markets. His expertise includes ICH Q7, EudraLex GMP, USFDA 21 CFR, Schedule M, ISO standards, supplier quality systems, gap assessments, CAPA follow-up, regulatory inspection preparation, electronic GxP compliance, and quality-system improvement. He also brings substantial training experience and has delivered numerous subject-matter expert programs covering GMP and quality compliance. - Show More
Adish has extensive experience planning and conducting GMP and broader GxP audits across pharmaceutical manufacturing environments. His audits cover APIs, finished pharmaceutical products, excipients, intermediates, packaging materials, and related operations, with assessments performed against regulatory requirements including ICH Q7, EudraLex GMP, USFDA 21 CFR, Schedule M, and applicable ISO standards. He can support organizations in identifying compliance gaps, assessing GMP systems, and developing practical recommendations for improvement.
Adish supports organizations with GMP compliance through audit assessments, gap analysis, quality-system review, regulatory interpretation, and remediation guidance. His experience includes USFDA 21 CFR, ICH Q7, EudraLex GMP, Schedule M, ISO requirements, and other applicable global standards. He previously served as Quality Compliance in-charge at a USFDA-approved drug-product facility that achieved an inspection outcome with zero Form 483 observations.
Adish has substantial experience delivering professional training on GMP, GxP compliance, documentation, personnel hygiene, and regulatory expectations. His assignment summary records 90 subject-matter expert training sessions, each involving at least 25 participants, demonstrating that training is a significant and established part of his consulting work.
Adish has strong knowledge and consulting experience in pharmaceutical Quality Management Systems, including quality documentation, risk management, CAPA, deviations, change control, complaint handling, audit management, and quality-system improvement. His freelance work also includes QMS gap analyses and consulting assignments aimed at strengthening compliance and improving existing quality systems.
Adish has extensive supplier qualification and supplier-audit experience covering APIs, excipients, key starting materials, intermediates, packaging materials, and contract manufacturing facilities. His earlier Corporate QA responsibilities included second-party supplier audits, vendor data management, audit follow-up, CAPA evaluation, and maintenance of approved-vendor systems. He can support pharmaceutical organizations in risk-based supplier assessment, vendor qualification, compliance monitoring, and supplier-quality oversight.
Third-party auditing is one of Adish’s strongest consulting capabilities. As a freelance auditor, he conducts independent on-site and remote audits of pharmaceutical manufacturers, API sites, excipient facilities, packaging-material manufacturers, medical-device companies, and other external partners. His assignments include first-, second-, and third-party audits across numerous countries, making him highly experienced in independent external compliance assessment.
