Hire Vijaya Kumar Pedinenikaluva, a pharma consultant specializing in Drug Development, 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: Vijaya Kumar Pedinenikaluva is a biopharmaceutical quality professional with 21 years of experience in quality assurance, GxP compliance, and manufacturing operations across biologics and biosimilars. His career includes roles with Lupin Biotech, Biocon Biologics, Mylan Pharmaceuticals, Dr. Reddy’s Laboratories, Biological E., and Indian Immunologicals. His expertise covers FDA inspection readiness, GMP audits, quality management systems, deviation investigations, corrective and preventive actions, and process validation. He also brings experience in biologics manufacturing and quality oversight of aseptic operations. An IRCA-certified Lead Auditor and Six Sigma Black Belt, he has led international regulatory inspections and supported technology transfers, regulatory filings, and global biosimilar launches. - Show More
Vijaya supports quality oversight of aseptic manufacturing, drawing on experience with aseptic blending, sterile filling, and biologics formulation operations. He helps organizations review manufacturing practices, associated documentation, and quality controls. His background in investigations and risk assessment also supports evaluation of deviations affecting aseptic operations.
Vijaya supports biologics and biosimilar operations through experience spanning manufacturing, quality assurance, investigations, and regulatory inspections. His background includes formulation, filling, and purification, alongside work supporting products such as Rituximab and Darbepoetin. He has also supported global launches of Trastuzumab, Peg-GCSF, Bevacizumab, and Etanercept, bringing a manufacturing and quality perspective to commercialization activities.
Vijaya supports CAPA management for pharmaceutical and biologics quality systems, drawing on experience overseeing CAPA lifecycles and using TrackWise for quality event management. He helps teams translate investigation findings into corrective and preventive actions, assess associated risks, and strengthen follow-up processes. His expertise is focused on manufacturing and pharmaceutical quality applications.
Vijaya supports deviation and failure investigations across biopharmaceutical manufacturing operations. His experience includes leading a centralized manufacturing investigation team and standardizing investigation methodologies and risk assessments across sites. He helps organizations investigate manufacturing events, identify root causes, document findings, and establish corrective and preventive actions to reduce recurrence.
Vijaya supports FDA inspection preparation through compliance reviews, quality system assessments, and coordination of inspection activities. His experience includes leading inspection readiness programs, hosting health authority audits, and managing responses to inspection findings. He helps organizations identify gaps, prepare supporting documentation, and align manufacturing and quality teams with inspection requirements.
Vijaya supports GMP audits and internal audit programs, drawing on his IRCA Lead Auditor certification and experience with international regulatory inspections. His background spans biologics manufacturing, quality assurance, and GxP compliance. He helps clients assess manufacturing controls, quality systems, data integrity, and documentation practices to identify areas requiring improvement.
Vijaya supports process validation and technology transfer activities in biologics manufacturing. His experience includes providing manufacturing QMS support for validation programs and coordinating quality requirements during technology transfers. He helps clients review supporting documentation, assess process-related risks, and align validation activities with site quality systems and regulatory readiness.
Vijaya supports pharmaceutical and biopharmaceutical quality assurance through experience leading site quality operations, analytical QA, and product release oversight. His background includes QA leadership for biologics drug substance manufacturing and third-party biosimilar operations. He helps organizations strengthen quality governance, documentation practices, and coordination between manufacturing and quality teams.
Vijaya supports the development and improvement of quality management systems for biopharmaceutical manufacturing. His experience includes managing manufacturing QMS performance, deviations, equipment validation activities, and regulatory readiness. He helps clients review quality processes, standardize investigation approaches, and strengthen documentation and risk assessment practices across manufacturing operations.
