Hire Dr. Pushpinder Paul, a pharma consultant specializing in Clinical Studies, FDA Inspections, Medical Devices, Pharmaceutical Manufacturing, Pharmaceutical Quality and Sterile Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Dr. Pushpinder Paul is a pharmaceutical and medical device quality consultant, principal auditor, and lead trainer. His expertise includes GMP audits, quality management systems, FDA inspection readiness, Good Clinical Practice audits, CAPA, facility qualification, media fill simulation, and sterility assurance. He has conducted more than 150 audits across multiple audit categories and delivered over 50 QMS and cGMP training programs. His career includes quality and compliance roles with Sentiss Pharma, Advanced MedTech Solutions, Glenmark, Ranbaxy, and Wockhardt. His consulting experience covers quality system implementation, compliance gap assessments, remediation planning, and international audit and training assignments. Combining manufacturing experience with auditing and training, he helps organizations strengthen quality systems, address deficiencies, and prepare for regulatory inspections. - Show More
Pushpinder supports CAPA development and review for pharmaceutical and medical device quality systems. His experience includes leading cross-functional investigations, reviewing corrective actions, and developing CAPA strategies during consulting assignments. He uses tools such as Why-Tree analysis, FMEA, fault tree analysis, and fishbone diagrams to help teams identify causes and strengthen corrective action effectiveness.
Pushpinder supports qualification of new pharmaceutical and medical device facilities, including greenfield projects and sterile manufacturing operations. His experience covers HVAC, cleanroom equipment, and utilities such as purified water, water for injection, pure steam, nitrogen, and compressed air. He reviews qualification documentation from user requirements through performance qualification and helps coordinate engineering and quality activities.
Pushpinder supports FDA inspection readiness through compliance gap assessments, quality system reviews, validation documentation oversight, and corrective action planning. His background includes leading regulatory inspection activities and coordinating audit responses within pharmaceutical quality functions. He helps teams assess supporting records, address identified deficiencies, and prepare manufacturing and quality systems for inspection.
Pushpinder conducts GMP audits for pharmaceutical manufacturers and suppliers, including API, formulation, excipient, and packaging material facilities. His experience includes internal audits, supplier audits, compliance assessments, and quality system reviews. He helps organizations identify gaps, document observations, and develop corrective actions, drawing on international auditing assignments and manufacturing quality experience.
Pushpinder delivers GMP and quality management system training for pharmaceutical manufacturing and quality teams. He has conducted more than 50 QMS and cGMP training programs and holds Train-the-Trainer certification. Drawing on practical auditing and manufacturing experience, he helps participants understand compliance expectations, apply approved procedures, and strengthen their approach to quality investigations and audit preparation.
Pushpinder supports GCP compliance through auditing experience involving full-service clinical research organizations. His background includes three documented GCP vendor audits, GCP auditor training, and education in clinical research and clinical data management. He helps organizations assess clinical research quality practices and supporting documentation against applicable GCP requirements and identify areas requiring corrective action.
Pushpinder supports aseptic process simulation through experience conducting media fill activities for sterile manufacturing operations. His background combines sterile production, validation, and quality oversight. He helps teams assess simulation activities and supporting documentation as part of evaluating aseptic process controls and contamination control practices.
Pushpinder supports quality management system implementation, assessment, and improvement for pharmaceutical and medical device organizations. His consulting experience includes gap assessments, remediation programs, and system implementation supporting ISO 9001 and ISO 13485 certification. He helps teams strengthen procedures, management reviews, quality oversight, and the handling of deviations, change controls, investigations, and CAPA.
Pushpinder supports sterility assurance through experience validating steam and dry heat sterilization systems, sterilization-in-place processes, and filtration controls. His work also includes review of bioburden, environmental monitoring, and bacterial endotoxin test reports. He helps sterile manufacturing teams assess validation evidence, strengthen contamination controls, and address related quality deficiencies.
