Quality Assurance Officer at Mission for Essential Drugs and Supplies (MEDS)

About the Role

This position reports to the Quality Assurance Supervisor and is responsible for maintaining strong overall quality assurance of products and services, ensuring conformity to set organizational and statutory requirements. The role ensures organizational compliance with the Quality Management System requirements as supplemented by ISO 9001:2015 standard, Good Distribution Practices (GDP), A Model Quality Assurance System for Procurement Agencies (MQAS), Good Practices for Pharmaceutical Quality Control Laboratories (WHO), and ISO 17025:2017 standard.

Key Responsibilities

• Improve the QMS compliance index by ensuring closure of quality events including deviations, corrective actions, preventive actions, and changes within stipulated timelines to ensure conformance to organizational QMS requirements
• Prequalify suppliers and products by conducting on-site supplier visits and remote review of supplier information, and product assessment to ensure suppliers and products meet set criteria
• Maintain a database of prequalified suppliers and products including critical records such as site questionnaires, pharmaceutical product questionnaires, screening and evaluation forms, licenses, certifications, and patient information leaflets
• Sample, evaluate, and test medical devices including rapid diagnostic test kits to ensure they meet specifications
• Investigate major quality complaints, including evaluation of products to ensure customer satisfaction
• Qualify and validate equipment and processes through preparation of qualification and validation protocols, and conduct qualification and validation to obtain scientific evidence that instruments meet their specifications
• Review product inspection checklists, sample and inspect inbound consignments, and resolve issues related to non-conforming products within stipulated timelines to make products available for sale and ensure customer satisfaction
• Prepare quality assurance documentation and reports as required