Quality Assurance Officer

The Kenya Medical Research Institute (KEMRI) is a state corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013 as the national body responsible for carrying out health research in Kenya.

Quality Assurance Officer – Mtwapa

Key responsibilities

1. Ensure adherence to ICH-GCP, local regulations, and ethical standards.
2. Monitor compliance with study protocols, SOPs, and sponsor requirements.
3. Identify deviations, non-compliances, or risks, and ensure CAPA (Corrective and Preventive Actions) are implemented.
4. Support inspection readiness for audits by regulatory authorities and sponsor.
5. Train clinical trial staff on GCP, SOPs, and QA best practices.
6. Provide ongoing QA guidance and support to research teams.
7. Identify and escalate quality issues or trends affecting trial integrity.
8. Develop and implement quality improvement initiatives based on audit findings and process reviews.
9. Assisting in preparing the project for monitoring of quality assurance Activities;
10. Assisting in carrying out internal audits on quality compliance and follow-up audits;
11. Oversee daily quality checks and error resolution

Vacancy Requirements:

• Bachelor’s Degree in Biomedical Sciences, Nursing, Health sciences or any other relevant field from a recognized Institution;
• Proficiency in computer application;
• One year of relevant experience in clinical research, or quality management.

Skills & Competencies

• Planning skills;
• Creativity and innovation skills;
• Analytical skills;
• Communication and reporting skills;
• Ability to work independently and Team player.
• Interpersonal skills