Hire Gopichand Pula, a pharma consultant specializing in FDA Inspections 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: Gopichand Pula is a senior Quality and Regulatory Compliance professional with over 18 years of experience across Quality Assurance, Quality Control, GMP Audit, GMP Compliance, Quality Management System, Third Party GMP Audit, Supplier Qualification, and FDA Inspection Readiness. His career spans pharmaceutical manufacturing, QA/QC operations, regulatory compliance, investigations, CAPA, OOS/OOT, change controls, data integrity, validation oversight, supplier quality, and audit management. He currently provides independent Quality and Regulatory Compliance consulting and has conducted cGMP, GLP, and GxP assessments of third-party manufacturing facilities against global regulatory requirements including USFDA, EU, MHRA, Health Canada, and WHO. His experience also includes mock audits, compliance gap assessments, supplier audits, QMS implementation, inspection-readiness support, and practical remediation planning. - Show More
Gopichand has experience supporting organizations with regulatory audit preparation through mock inspections, gap assessments, documentation reviews, CAPA coordination, and remediation planning. His consulting work specifically includes regulatory audit readiness and mock audits designed to identify compliance deficiencies before formal inspections.
Gopichand is actively seeking GMP audit and gap-assessment assignments and has direct experience performing GMP, GLP, and GxP compliance audits. His audit work includes evaluation of facilities, systems, documentation, quality processes, and manufacturing practices to identify compliance gaps and recommend appropriate improvements.
Gopichand has extensive experience supporting compliance with cGMP and global regulatory expectations. His background covers quality-system compliance, data integrity, CAPA, investigations, documentation review, inspection preparation, and gap assessments aligned with requirements from authorities and standards including USFDA, MHRA, TGA, Health Canada, WHO-GMP, and others.
Gopichand has extensive Quality Assurance experience across pharmaceutical manufacturing operations. His responsibilities have included deviations, change controls, CAPA, complaints, investigations, risk management, validation oversight, documentation review, and regulatory compliance. During his long tenure in QA, he was responsible for maintaining effective quality systems and supporting continuous inspection readiness.
Gopichand has strong hands-on Quality Control experience from his roles at Aurobindo Pharma and Ranbaxy Laboratories. His work has included analytical documentation, OOS/OOT investigations, analytical method validation, testing of raw materials, APIs, intermediates and finished products, stability activities, laboratory data review, and use of analytical and LIMS systems.
Gopichand has significant experience implementing and managing pharmaceutical Quality Management Systems. His work includes deviations, change control, CAPA, complaints, investigations, risk management, data integrity, and quality-system governance. He can support organizations in evaluating existing QMS processes, identifying weaknesses, and implementing practical improvements.
Gopichand has practical experience in vendor qualification and supplier auditing as part of pharmaceutical quality operations. He can support organizations in supplier evaluation, compliance assessment, quality-system review, risk identification, and ongoing supplier oversight.
Gopichand has directly conducted GxP and regulatory compliance audits of third-party manufacturing sites. His consulting experience includes evaluating external facilities against USFDA, EU, MHRA, Health Canada, and WHO requirements, making third-party GMP auditing a strong independent consulting capability.
