Hire Dr. Mukesh 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: Dr. Mukesh Gupta is a freelance GMP auditor, trainer, and pharmaceutical quality consultant with 29 years of experience in pharmaceutical organizations and additional freelance consulting experience. He has held senior quality positions with Gracure Pharmaceuticals, IPCA Laboratories, Cipla, Sidmak Laboratories, Unichem, Glenmark, Torrent Pharmaceuticals, and Nicholas Piramal. His expertise includes GMP auditing, third party audits, supplier qualification, FDA inspection readiness, quality assurance, quality control, and quality management systems. He also supports facility qualification and has delivered more than 300 training sessions covering GMP, validation, QMS, and GLP. A Ph.D. holder in Chemistry and certified ISO 9001:2015 QMS Lead Auditor, he brings experience across tablets, capsules, liquids, ointments, inhalers, and sterile products. - Show More
Mukesh supports facility qualification activities through experience in pharmaceutical qualification, validation, and compliance documentation. His background includes supporting the setup of a sterile ophthalmic facility with responsibility for documentation, validation, qualification, and compliance. He helps clients review the qualification documentation and quality requirements associated with establishing pharmaceutical manufacturing facilities.
Mukesh supports FDA inspection preparation through GMP gap assessments, documentation review, and coordination of site quality activities. His experience includes facing two US FDA inspections at Cipla and overseeing inspection preparation at Sidmak Laboratories. Having independently managed regulatory audits as a QA Head, he helps manufacturing and laboratory teams identify gaps, organize supporting records, and prepare for inspection activities.
Mukesh conducts GMP audits and gap assessments for pharmaceutical manufacturing facilities and supporting operations. His experience covers finished formulations, APIs, excipients, packaging materials, and testing laboratories. Drawing on his knowledge of US FDA requirements, EU GMP, and Schedule M, he helps organizations assess manufacturing practices, quality documentation, and laboratory controls to identify compliance gaps and improvement priorities.
Mukesh delivers GMP training for pharmaceutical manufacturing, quality assurance, quality control, and supporting teams. He has conducted more than 300 sessions covering GMP, validation, quality management systems, and GLP, including GMP training for IT personnel. His programs draw on practical manufacturing and auditing experience to help employees understand quality requirements and apply them to their responsibilities.
Mukesh provides quality assurance support based on senior leadership experience overseeing QA and QC functions across multiple pharmaceutical dosage forms. His expertise includes in-process quality assurance, QA documentation, validation oversight, investigations, and audit management. He helps organizations strengthen quality oversight and improve coordination between manufacturing, laboratories, and other functions involved in maintaining pharmaceutical quality.
Mukesh supports pharmaceutical quality control through experience managing analytical testing, GLP practices, laboratory investigations, and validation activities. His background includes QC leadership at Nicholas Piramal and overall laboratory oversight in subsequent quality roles. He assists clients with reviewing analytical data, QC documentation, instrument-related practices, and out-of-specification investigations to strengthen laboratory controls.
Mukesh supports the implementation and improvement of pharmaceutical quality management systems. His experience includes quality documentation, investigations, CAPA monitoring, audit management, and system implementation. He is familiar with pharmaceutical software platforms including SAP, TrackWise, DMS, BMS, and LIMS. He helps clients review quality workflows and establish consistent documentation and follow-up practices across operations.
Mukesh supports supplier qualification through vendor audits, compliance assessments, and CAPA monitoring. His experience includes API, excipient, packaging material, disinfectant, and finished formulation manufacturers, along with external testing laboratories. He has also audited a primary packaging material supplier in Manchester, UK, and conducted container supplier investigations. He helps clients evaluate supplier quality controls and follow up on identified deficiencies.
Mukesh provides independent third party GMP audits in association with international organizations. His audit experience includes 78 API manufacturing units, 42 excipient manufacturing units, 10 finished pharmaceutical manufacturing units, 12 packaging material facilities, and five public testing laboratories. He supports clients in assessing external partners’ quality practices and reviewing compliance actions arising from audit findings.
