TIISETSO ERIC MAKHATA

• Ensure compliance with Good Manufacturing Practice (GMP), Food and Drug Administration (FDA), and other regulatory standards through regular audits and process monitoring. • Develop, review, and maintain Quality Assurance documentation, including SOPs, batch records, and deviation reports. • Lead investigations into product quality issues and non-conformances, conducting root cause analysis and implementing Corrective Action and Preventive Action (CAPA). • Coordinate and conduct Internal and External audits, working closely with regulatory authorities during inspections. • Collaborate with production, Research and Development (R&D), and Quality Control teams to ensure continuous quality improvement. • Implemented process improvements, reducing non-compliance events. • Provide training to staff on Quality Management Systems and GMP compliance. • Monitor and analyze trends in quality performance metrics and suggest corrective actions as necessary.

• Supervised Laboratory personnel, ensuring adherence to protocols and regulatory guidelines. • Conducted routine testing of raw materials, in-process samples, and finished products to ensure compliance with quality standards. • Managed day-to-day laboratory operations, optimizing workflow efficiency and resource utilization. • Trained and mentored Laboratory staff, fostering a culture of continuous learning and professional development. • Implemented and improved SOPs to enhance Laboratory efficiency and minimize errors. • Ensured accurate documentation of test results and compliance with GMP standards. • Worked closely with production teams to monitor critical control points and support continuous improvement efforts. • Assisted in troubleshooting and resolving quality issues, including root cause analysis and CAPA initiatives. • Collaborated with the quality assurance (QA) department to provide support during regulatory inspections and audits.

• Sample collection and preparation on blood, urine, milk, faecal and tissue samples to aid in Disease detection and treatment depending on protocols, ensuring chain of custody and avoiding contamination. • Ensured Laboratory compliance with medical regulations and Quality control standards. • Operated and maintained Laboratory instruments, ensuring optimal functionality. • Assisted in the development and implementation of new Laboratory techniques and Procedures. • Accurately record and analyze test results. • Verify and validate results before reporting. • Maintain confidentiality and ensure proper data security.