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

The position reports to the Quality Assurance Supervisor and will be responsible for maintaining strong overall quality assurance of products and services, ensuring conformity to set organizational and statutory requirements. The role is also responsible for ensuring organizational compliance to the requirements of the Quality Management System 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 and preventive actions, and changes within the stipulated timelines to ensure conformance to MEDS QMS requirements.
• Prequalify suppliers and products by conducting on-site supplier and remote review of supplier information, and product assessment to ensure the suppliers and products meet the set criteria.
• Maintain a database of prequalified suppliers and products including critical records e.g. 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 meets specifications.
• Investigate major quality complaints, including evaluation of the products to ensure customer satisfaction.
• Qualify and validate equipment and processes, through preparation of qualification and validation protocols, conduct qualification and validation to obtain a scientific evidence that the instrument meets its specifications.
• Review product inspection checklists, sample and inspect inbound consignments and resolve issues related to non-conforming products within the stipulated timelines to make the products available for sale and for customer satisfaction
• Prepare quality assurance QMS documents to ensure conformance to the MEDS Quality Management System, statutory and regulatory requirements
• Implement projects related to Quality Assurance to ensure the scope is determined; resources are well-managed and timelines met.
• Implement the approved internal quality audit plan to ensure all audits are conducted on time and non-conformities identified are closed within the stipulated timelines.
• Screen incoming products and consignments using Near-Infrared Spectrophotometry technology to assure their quality prior to release for sale.
• Conduct product recalls and collate information required for pharmacovigilance of MEDS products as a requirement by Pharmacy and Poisons Board.
• Conduct daily environmental monitoring of controlled areas within MEDS premises to ensure adherence to set limits of temperature and relative humidity as established by international guidelines.
• Conduct technical activities in the warehouse and laboratory, ensure compliance to MQAS, GDP, ISO 17025:2017 and World Health Organization’s Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL).
• Train new and existing staff on requirements of the quality management system.

Candidate Profile:

• Bachelor’s degree in Pharmacy, Medicine, Medical Laboratory Science, Biochemistry, Biological Sciences, Clinical Medicine, or Nursing from a recognized institution.
• Registered with the relevant professional body i.e. Pharmacy and Poisons Board (PPB), Nursing Council of Kenya or Kenya Medical Laboratory Technicians & Technologists Board
• Training in Quality Management System from accredited body is an added advantage
• Minimum of five (5) years of relevant experience in QMS in a GDP or GMP facility
• Technical competencies; Knowledge of Model Quality Assurance System for Procurement Agencies (MQAS); Knowledge of Good Storage & Distribution Practices; Good Manufacturing Practices; Guidelines on Safety and Vigilance of Health Products & Technologies; Good Laboratory Practices; ISO 9001:2015 Quality Management Systems
• Behavioural attributes; Communication; Problem solving; Analytical; Innovation; Interpersonal skills; Team Player; high level of integrity, self driven  and keen to details