Eliud Hungulu

• Provide quality oversight across production laboratories, ensuring vaccine manufacturing processes align with GMP, GLP, and ISO/IEC 17025 standards. • Lead the development, review, and optimization of Standard Operating Procedures (SOPs) for vaccine blending, diluent preparation, and media formulation. • Support GMP implementation within the production department by coordinating internal audits, CAPA investigations, and documentation standardization. • Collaborate with cross-functional teams to ensure regulatory readiness, risk mitigation, and continuous improvement of quality systems. • Monitor documentation integrity, including batch records, equipment calibration logs, and deviation reports, to maintain audit compliance. • Mentor staff and interns on quality-focused practices, technical documentation, and regulatory protocols. • Actively contribute to KEVEVAPI’s GMP Committee, providing strategic input on quality governance and system-wide compliance initiatives.

• Conduct technical assessments and audits of testing and calibration laboratories to evaluate compliance with ISO/IEC 17025:2017 standards. • Review laboratory procedures, equipment calibration records, and quality management systems to determine conformity and operational competence. • Prepare comprehensive audit reports detailing findings, non-conformities, and recommended corrective actions to support accreditation decisions. • Provide expert guidance on process optimization, documentation integrity, and risk mitigation strategies. • Collaborate with laboratory personnel and regulatory bodies to enhance quality systems and ensure sustained compliance. • Support national efforts to strengthen conformity assessment infrastructure and promote international recognition of accredited laboratories.

• Provide strategic advisory on ISO/IEC 17025, GMP/GLP systems, and regulatory compliance. • Conduct mock audits, gap assessments, and staff training for accreditation readiness. • Support clients in SOP development, CAPA management, and quality system optimisation. • Collaborate with national and international bodies to align operations with global standards.

Perform routine and complex analyses using HPLC instruments, ensuring adherence to standard operating procedures (SOPs) and regulatory guidelines. Contribute to the development and optimization of HPLC methods, troubleshooting issues, and recommending improvements to enhance efficiency and accuracy. Maintain and troubleshoot HPLC instruments, ensuring proper functioning, calibration, and performance verification. Analyze and interpret chromatographic data, prepare detailed reports summarizing analysis results, and communicate findings to relevant stakeholders. Implement and maintain quality control measures, participate in quality assurance activities, and adhere to GMP/GLP standards. Conducted on job training and training for incoming employees and internship students

Perform various wet chemistry tests, including titrations, pH measurements, dissolution tests, and other qualitative and quantitative analyses as per standard procedures. Follow established protocols and methodologies for wet chemistry testing, ensuring accuracy, precision, and reproducibility of results. Operate and maintain laboratory equipment and instrumentation relevant to wet chemistry analysis, ensuring proper calibration and functionality. Adhere to quality control measures, participated in quality assurance activities, and documented test results accurately in compliance with regulatory guidelines and SOPs. Analyze and interpret test results, prepare detailed reports summarizing findings, and communicate results to relevant stakeholders.

Conduct routine inspections and checks during different stages of production to ensure adherence to quality standards and manufacturing procedures. Collect samples from various production stages, perform analyses using appropriate techniques or instruments, and interpret results to verify product quality. Maintain accurate records of inspections, test results, and deviations encountered during the production process. Prepare detailed reports outlining findings and any necessary corrective actions. Work closely with production teams, quality assurance personnel, and other stakeholders to address quality concerns, implement improvements, and maintain consistency in product quality. Ensure compliance with relevant regulatory standards (such as GMP/GLP) and company policies throughout the manufacturing process.