Itumeleng Moeketsi, MSc

Establishing and maintaining a Facility Specific Safety Manual. Ensuring that laboratory staff comply with the Laboratory Specific Safety Manual for manufacturing within the BSL 2+/3 facility. Providing documented, periodic safety and operations training as needed. This shall include emergency drills and table-top exercises involving BSL2+/3 clean room facility personnel. Maintaining equipment inventory and working with the Maintenance Unit for regular maintenance/service. Being responsible for safe day-to-day operation of the BSL2+/3 Facilities. Acting as the Biosafety and Hazardous Waste Officer. Championing facility design and procedures in line with BSL2+/3 requirements. Providing Unit with Laboratory administration services including purchasing of supply and equipment, maintaining required safety and operations documentation, and assisting staff with laboratory operations management. Supervising/ensuring regular maintenance activities including annual shut-down, verification/re-certification of the BSL 2+/3 cleanroom facility. Supervising maintenance and compliance with BSL2+/3 infectious agents’ inventory (seed management). Data management and laboratory and product trend cards. Implementation of internal (between laboratory personnel in full PPE / between the anteroom and the laboratory) and external (between BSL2+/3 laboratory and emergency response unit) communication systems. Performance of risk assessment in line with other relevant internal units for the laboratory before commissioning of the laboratory for production. Writing of facility, equipment, and production SOPs. Production and planning of all manufacturing procedures according to annual forecasts and sales demands. Completion of batch documentation and all relevant documentation related to manufacturing. Championing six-monthly (or biannual?) internal audits from the QA department. Setting up and maintaining of a biosafety/biosecurity program. Setting up adequate waste management procedures.

Create batch production/equipment/facility SOP, protocol and log sheets for new and existing products, in collaboration with the R&D, QA and QC units and in accordance with the requirements of the quality management system for aerobic fermentation, small scale formulation, small scale filling and BSL3. Assist with operation and maintenance of isolators and filling lines (BSL3). Assist with the Occupational Health and Safety program. Assistance with after-hours monitoring of temperature logging system Manage all aspects of manufacture of bacterial vaccine antigens according to the standards and procedures described in the relevant dossier. Provides administrative support and management of the BSL 3 manufacturing facility Establishes any necessary scheduling and usage of laboratory resources. Assist with the establishment and implementation of bio-safety, security, and common laboratory standard operating procedures and processes in Bio-safety Level 3. Provide continuous operations and safety training for new staff and current. Liaise with QC and QA departments. Assist with establishing and maintaining Facility Specific Safety Manual (BSL3). Ensure that laboratory staff establish and maintain Laboratory Specific Safety Manual for manufacturing within the BSL 3 facility. Provide documented, periodic safety and operations training as needed. This shall include emergency drills and table-top exercises involving BSL3 clean room facility personnel. Maintain equipment inventory and work with the Operations Unit for regular maintenance/service. Responsible for safe day-to-day operation of the BSL3 Facilities. Acts as the Bio-Safety and Hazardous Waste Officer. Assist with facility design and procedures in line with BSL3 requirements. Provide Department with Laboratory Administration services including purchasing of supply and equipment, maintaining required safety and operations documentation, and assisting staff with laboratory operations management.

Assist with the development of protocols for the testing and manufacture of new vaccines. Create batch production documentation for new products in collaboration with R&D unit and in accordance with the requirements of the quality management system. Manage all aspects of manufacture of bacterial vaccine antigens according to the standards and procedures described in dossiers. Formulate bacterial vaccines. Prepare and characterise master seed antigens along with the required documentation. Prepare working seed antigens and managing of back-up and off-site storage of working seeds. Document all required records and details for each manufactured batch of vaccine antigen. Generate, co-ordinate and collate all batch documentation. Manage raw material and final product stock. Assist with operation and maintenance of isolators and filling lines. Assist with the Occupational Health and Safety programme. Assistance with after-hours monitoring of temperature logging.

Manufacturing and sterile filling of Animal vaccines, Biological products and chemical products as per standard operating procedures. Ensuring that manufacturing processes are in compliance with GMP and ISO9000 standards. Operation of various production equipment (Homogenisers, Industrial boilers, Reverse Osmosis Water systems, Clean Steam generators and production vessels). CIP and SIP of production plants. Ensuring adequate supply of raw materials for production. Writing, reviewing and updating of standard operation procedures. Contribute to planning, design, and commissioning of new equipment and processes. Provide engineering and technical expertise to troubleshoot technical or production problems. Assistance and maintenance of equipment and calibration of instruments. Ensuring that products are made on time and according to the production schedule. Knowledge of clean room practices and aseptic processing/technique in a Pharmaceutical and Manufacturing environment. Downstream and aseptic processing.

Monitoring of stock levels of clean-in-place (CIP) detergents and ordering of stock. Monitoring of CIP detergents concentration/conductivity and reporting of out of specification results to management. Preparation of bulk descaling CIP detergents used in cleaning & descaling of fermentation vessels, beer storage vessels and bright beer tanks vessels. CIP of make-up tanks used for the make-up of CIP detergents. Transferring/pumping of bulk CIP detergent to storage flo-bins. Report writing

Research Project in Life Sciences, Research Methodology, Advanced Medical Microbiology, Advanced Industrial Microbiology and Biotechnology, Molecular Techniques Research Project: Production process optimisation for Histophilus somni whole cell vaccines in Single Use Bioreactors (SUB)

Introduction and Strategic role of Production/Operations Management; Designing, Planning and Controlling the Production/Operations Management; Improving the Production/Operations Management; Basics of Productivity Management.

Microbiology; Food Microbiology; Biochemistry; Microbial biochemistry; Analytical Biochemistry; Chemistry; Analytical Chemistry; Bioprocessing; Fermentation Technology; Mathematics & Statistics; Process technology & Management; Disease & Immune response; Biodiversity & Ecology; Sanitation, Safety & hygiene.