Hire K. CH. V. Gangadharam, 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: K. CH. V. Gangadharam is a pharmaceutical quality assurance professional with experience in API manufacturing, oncology compounds, peptides, and CDMO operations. His expertise includes quality assurance, quality management systems, GMP audits, FDA inspection readiness, supplier qualification, process validation, cleaning validation, equipment qualification, and facility qualification. His career includes quality leadership roles with Honour Synthesis, Biocon, Dr. Reddy’s Laboratories, Aurore Pharmaceuticals, and GVK Biosciences. A CQI-IRCA certified lead auditor, he has managed international regulatory inspections and customer audits, supported product validations, and coordinated technology transfers to external manufacturers. His background also includes computerized system validation, data integrity, quality risk assessments, and investigation management. He helps pharmaceutical teams strengthen manufacturing controls, improve quality documentation, and address compliance gaps. - Show More
Gangadharam supports cleaning validation through preparation of cleaning matrices and review and approval of validation documentation. His experience includes considering product portfolios, permitted daily exposure data, analytical method readiness, and equipment requirements during technology transfer. He helps teams coordinate cleaning validation activities and maintain supporting risk assessments and study records.
Gangadharam supports pharmaceutical equipment qualification through experience with URS, DQ, IQ, OQ, and PQ activities for process equipment. His background combines manufacturing operations with quality review and approval of qualification records. He also supports computerized controls associated with PLC, SCADA, and MES systems, helping teams coordinate qualification and validation requirements.
Gangadharam supports facility qualification through experience in greenfield projects, facility modifications, and high-potency API qualification activities. His work includes HVAC and water system qualification, facility risk assessments, and review of supporting documentation. He helps project and quality teams assess facility suitability for new products, technology transfers, and scale-up activities.
Gangadharam supports FDA inspection readiness through experience leading and supporting USFDA inspections at API manufacturing sites. His work combines audit preparation, quality system review, plant rounds, documentation oversight, and responses to inspection findings. He helps teams assess readiness, organize supporting records, and address compliance gaps through documented corrective and preventive actions.
Gangadharam supports GMP audits through experience conducting vendor assessments and managing internal audit activities. His background includes auditing key starting material, packaging material, advanced intermediate, and API suppliers in India and overseas. As a certified lead auditor, he helps teams assess quality practices, document findings, and coordinate responses and corrective actions.
Gangadharam supports process validation through experience overseeing product validations and technology transfers from R&D to commercial manufacturing and third-party sites. His work includes process feasibility assessments, validation document review and approval, and coordination of trial and validation batches. He helps teams establish documented validation activities supporting commercialization and regulatory filing requirements.
Gangadharam supports pharmaceutical quality management systems through experience managing deviations, OOS/OOT investigations, CAPA, change controls, complaints, and returned goods. His work includes root cause analysis, quality trend reviews, management reviews, and CAPA effectiveness verification. He helps organizations strengthen investigation records, identify recurring issues, and improve quality system performance.
Gangadharam supports pharmaceutical quality management systems through experience managing deviations, OOS/OOT investigations, CAPA, change controls, complaints, and returned goods. His work includes root cause analysis, quality trend reviews, management reviews, and CAPA effectiveness verification. He helps organizations strengthen investigation records, identify recurring issues, and improve quality system performance.
Gangadharam supports supplier qualification through vendor audits, quality assessments, and review of compliance documentation. His experience covers key starting materials, packaging materials, advanced intermediates, and APIs, alongside oversight of contract manufacturing and research partners. He helps organizations evaluate supplier capabilities and coordinate quality requirements for outsourced manufacturing and testing activities.
