Meshack Odenyo

Delivered clinical trial training programs, boosting staff proficiency by 30%, reducing review errors by 25%, and expediting inspection readiness.
Optimized pharmacovigilance systems, achieving 98% on-time case submissions, 95% data accuracy, and 30% faster signal detection through automation.

Implemented risk management strategies across product lifecycle, reducing development cycle time, lowering product deviations, and minimizing adverse event reporting rates by 25% through proactive safety planning.
Designed and implemented country-specific roadmaps with work plans, timelines, and KPIs, boosting technical assistance efficiency by 20% across 10+ countries.

Implemented QMS policies and SOPs, boosting consistency by 25% and cutting compliance deviations by 30%.
Led GMP and East Africa Harmonization approvals, reducing regulatory delays by 40% and compliance costs by 35%.
Facilitated technology transfer, speeding up scale-up by 20% and improving collaboration by 30%.

Manufactured processes according to GMP and SOPs ensuring product quality, safety and regulatory compliance.
Developed and implemented Quality Management policies, validation policies, validation master plan and programs delivering consistent, high-quality products, boosting employees' engagement and reducing errors.

Increased revenue growth by 15% and reduced approval timelines by 3 months, driving dossier submissions and regulatory approvals for 285 pharmaceutical products across 15 African countries expanding market access.
Streamlined manufacturing operations and enforced WHO Pre-qualification quality controls, improving compliance, reducing defects by 25%, and increasing production efficiency by 20%.

Developed project plans on dossier preparation, GMP readiness and submission workflows ensuring accuracy, compliance and timely execution.
Oversaw dossier submissions, responded to WHO queries, managed post submission follow-ups to align cross functional teams, reducing approval timelines by 30%, and ensuring 100% compliance with regulatory standards.

Ensured proper management and safe keeping of Quality Assurance records in compliance with cGMP guidelines, achieving 100% audit readiness and easy retrieval time by 85% via system optimization.
Led in-house GMP and regulatory compliance training programs, achieving 100% staff participation and reducing non-compliance deviations by 30% through continuous system monitoring and adherence tracking.

Grade: 3.5

Currently pursuing a PhD in Agricultural & Biological Engineering with a specialization in Biotechnology Innovation & Regulatory Sciences. This advanced program focuses on the intersection of biological engineering and regulatory frameworks.

Completed a Master of Science in Biotechnology Innovation and Regulatory Science. The program provided in-depth knowledge and skills in the regulatory aspects of biotechnology.

Grade: 3.5

Obtained a Diploma in Advanced Industrial Pharmacy. This program focused on specialized aspects of industrial pharmaceutical practices.

Grade: 4.0 First Class Honors

Graduated with First Class Honors in Bachelor of Science (BSc. Pharmacy). The curriculum covered comprehensive pharmaceutical sciences and practices.