Quality Assurance Officer - Mtwapa - 3 Posts at Kenya Medical Research - KEMRI

Key Responsibilities:

• Ensure adherence to ICH-GCP, local regulations, and ethical standards.
• Monitor compliance with study protocols, SOPs, and sponsor requirements.
• Identify deviations, non-compliances, or risks, and ensure CAPA (Corrective and Preventive Actions) are implemented.
• Support inspection readiness for audits by regulatory authorities and sponsor.
• Train clinical trial staff on GCP, SOPs, and QA best practices.
• Provide ongoing QA guidance and support to research teams.
• Identify and escalate quality issues or trends affecting trial integrity.
• Develop and implement quality improvement initiatives based on audit findings and process reviews.
• Assisting in preparing the project for monitoring of quality assurance Activities;
• Assisting in carrying out internal audits on quality compliance and follow-up audits;
• 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;    Mandatory
• Proficient in computer applications;    Mandatory
• One year of relevant experience in clinical research, or quality management.    Mandatory
• Planning skills;    Mandatory
• Creativity and innovation skills;    Mandatory
• Analytical skills;    Mandatory
• Communication and reporting skills;    Mandatory
• Interpersonal skills;    Mandatory
• Ability to work independently and Team player.    Mandatory