Hire Kamesh Yeditha, a pharma consultant specializing in Analytical Testing, 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: Kamesh Yeditha is a pharmaceutical quality and compliance professional with 28 years of experience across corporate quality operations, quality assurance, quality control, and API manufacturing. An ASQ Certified Quality Auditor with certification in GMP Supplier Management, his expertise includes GMP audits, FDA inspection readiness, mock inspections, supplier qualification, quality management systems, deviation investigations, GMP training, and analytical method validation. His career includes senior leadership roles with Honour Lab, Par Active Technologies, and Hetero Drugs. He has led or supported more than 20 international regulatory inspections and provided corporate quality oversight across six manufacturing units, helping organizations strengthen quality systems, address compliance gaps, and improve inspection preparedness. - Show More
Kamesh supports deviation investigations through review of process events, out-of-specification and out-of-trend results, and associated quality risks. His experience includes assessing product failures and ensuring that related corrective and preventive actions are implemented. He helps teams strengthen investigation documentation, evaluate recurring trends, and assess action effectiveness to reduce repeat quality issues.
Kamesh supports FDA inspection readiness through compliance assessments, site walkthroughs, documentation reviews, and coordination of remediation activities. His experience includes leading or supporting US FDA inspections across several manufacturing organizations. He helps teams identify gaps, prepare quality records, track regulatory commitments, and strengthen the systems and operational practices needed to maintain inspection preparedness.
Kamesh conducts GMP audits and self-inspections to assess pharmaceutical manufacturing practices, quality systems, and supporting documentation. As an ASQ Certified Quality Auditor, he brings experience in internal and compliance audits, gap assessments, and audit follow-up. He helps organizations prioritize findings, establish remediation actions, and evaluate whether corrective measures effectively address identified deficiencies.
Kamesh delivers GMP and role-specific training for pharmaceutical quality and manufacturing teams. His experience combines practical API manufacturing knowledge with site and corporate quality leadership. He helps employees understand approved procedures, documentation responsibilities, and quality system requirements, using training to strengthen compliance awareness and improve the consistent application of GMP practices.
Kamesh supports analytical method validation through hands-on experience preparing protocols, executing studies, and compiling reports for APIs and pharmaceutical products. His background includes validation for assay, related substances, residual solvents, and cleaning methods, alongside impurity profiling and assessment of stability-indicating methods. He also brings senior QA experience reviewing and approving analytical validation documentation.
Kamesh supports mock FDA inspections as part of structured site readiness programs. His experience includes coordinating mock inspections, conducting site walkthroughs, and assessing quality system and documentation gaps before regulatory visits. He helps manufacturing and quality teams evaluate preparedness, prioritize corrective actions, and follow up on findings through remediation tracking and effectiveness verification.
Kamesh supports pharmaceutical quality assurance through experience leading site QA operations and corporate quality oversight across multiple manufacturing units. His work includes batch release oversight, review of manufacturing and analytical records, validation governance, and approval of quality documentation. He helps organizations strengthen quality responsibilities, standardize procedures, and coordinate manufacturing, laboratory, and support functions to maintain consistent quality controls.
Kamesh supports the development, implementation, and improvement of pharmaceutical quality management systems. His experience covers deviations, CAPA, change control, complaints, documentation control, quality risk management, and management reviews. He also brings experience with electronic quality platforms and quality performance metrics, helping organizations harmonize procedures across sites and identify recurring compliance risks through trend analysis.
Kamesh supports supplier qualification and ongoing supplier quality oversight through risk assessments, supplier audits, qualification record reviews, and performance monitoring. His experience includes approved supplier list governance, quality agreements, compliance questionnaires, regulatory declarations, and audit response assessment. He helps organizations maintain documented supplier approval decisions and follow up on corrective actions affecting outsourced materials and services.
