Quality Assurance Officer – Mtwapa (3 vacancies) at Mtwapa

Quality Assurance Officer - Mtwapa

• 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