Hire Dr. Vinod Gupta, a pharma consultant specializing in Drug Development, FDA Inspections, Medical Devices, Pharmaceutical Quality and Sterile Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: U.S.A.
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Dr. Vinod Gupta is an independent pharmaceutical quality consultant with over 25 years of experience across quality assurance, quality systems, sterile drug products, biologics, and advanced therapies. His expertise includes deviation investigations, root cause analysis, CAPA development, change management, complaints handling, and FDA-483 response writing. His career includes quality leadership roles with Organon, DPT Laboratories, Actavis, Novartis, and Castle Creek Pharma, alongside consulting assignments with Sanofi, Fujifilm Diosynth Biotechnologies, Catalent Biologics, Atara Biotherapeutics, and Meridian Medical Technologies. He holds a Ph.D. in Pharmaceutics from Rutgers University and brings extensive experience preparing investigation reports, establishing quality documentation, and supporting timely batch disposition. - Show More
Vinod supports aseptic manufacturing from a quality and investigation perspective, drawing on experience with sterile drug product deviations, aseptic processing practices, and contamination control strategy. He also taught sterile drug product manufacturing at Rutgers University. He helps teams assess manufacturing quality events and prepare documentation supporting investigations and improvements to aseptic practices.
Vinod supports biologics quality operations through experience investigating deviations involving sterile biological drug substances and finished drug products. His background includes assignments with Sanofi, Fujifilm Diosynth Biotechnologies, and Catalent Biologics, alongside cell and gene therapy QA responsibilities at Novartis. He helps teams address quality events through structured investigations, change documentation, and corrective action planning.
Vinod supports CAPA program development and implementation through experience translating investigation findings into corrective and preventive actions. His background includes pharmaceutical, biologic, and medical device quality investigations, alongside continuous improvement of quality procedures. He helps cross-functional teams connect actions to identified root causes and coordinate timely implementation.
Vinod supports pharmaceutical change management through experience authoring change controls for quality control operations and advanced therapies. His work at Atara Biotherapeutics, Novartis, and Actavis included change documentation, SOP improvements, and product risk assessments. He helps teams prepare technically clear change records and document the quality considerations associated with proposed changes.
Vinod supports pharmaceutical complaints handling through experience improving complaint investigations within third-party quality assurance operations. His background combines root cause analysis, investigation report writing, and CAPA implementation. He helps teams assess complaint-related information, prepare clear investigation records, and connect documented findings with appropriate corrective and preventive actions.
Vinod conducts cross-functional root cause analyses and prepares detailed deviation investigation reports for sterile drug substances, drug products, biologics, and medical devices. His consulting assignments include investigations at Sanofi, Fujifilm Diosynth Biotechnologies, Catalent Biologics, and Meridian Medical Technologies. He helps teams evaluate evidence, document findings, and develop actionable recommendations supporting deviation closure and batch disposition.
Vinod supports FDA-483 response preparation through his stated expertise in response writing, root cause analysis, and CAPA program development. His experience authoring investigation reports, SOPs, and risk assessments supports the documentation needed to address inspection observations. He helps teams present investigation findings and proposed corrective actions clearly in written responses.
Vinod supports pharmaceutical quality assurance through experience leading quality operations, overseeing batch release, and reviewing manufacturing quality events. His background includes directing a team of 25 QA associates and improving batch record review processes. He helps organizations strengthen quality oversight, prepare clear investigation documentation, and support timely, documented batch disposition decisions.
Vinod supports the establishment and improvement of pharmaceutical quality management systems. His experience includes authoring quality manuals and foundational SOPs, establishing third-party quality agreements, and implementing systems for the manufacture and release of global clinical supplies. He helps organizations define quality responsibilities and improve procedures for investigations, change controls, CAPAs, and product release.
