Raymond Manjengwa

o Preparation, review, and submittion of pharmaceutical product dossiers in CTD format, registration files, and other regulatory documents to regulatory authorities o Monitoring updates to regulatory guidelines and communicate changes to relevant teams. o Manage the registration, licensing, and renewal processes for products and premises o Establishments & maintainance of a Quality Management System o Compliance of all National Generics premises, pernonel and products

Oversight of Annual Product Quality Reviews and Water system • Oversight of Equipment Qualification, Utilities, Cleaning, Analytical Method and Process Validation activities • Implementation of Quality Management System • Implementation of Change Control System • GMP Compliance training and implementation • Implementation of Quality Risk Management and CAPA System • Internal and external auditing, reporting and training • Implementation of Validation Program and Preventative Maintenance Program • Compilation and implementation of Site Master File, Validation and Quality policy • Implementation and review of documentation system • Vendor approval, auditing and compilation of Quality Technical Agreements • Implementation of investigations, Complaints and Recall system • Coordination and chairing of Quality Management Reviews • Final approver of all Standard Operating Procedures, Monographs, Protocols and Specifications • Oversight of Microbiology Laboratory and functions • Supervision and Management of Quality Assurance staff • Review of Environmental monitoring data and trends

• Annual Product Quality Reviews and Water system • Equipment Qualification, Utilities, Cleaning, Analytical Method and Process Validation activities • Implementation of Quality Management System • Implementation of Change Control System • GMP Compliance training and implementation • Implementation of Quality Risk Management and CAPA System • Internal and external auditing, reporting and training • Implementation of Validation Program and Preventative Maintenance Program • Compilation and implementation of Site Master File, Validation and Quality policy • Implementation and review of documentation system • Vendor approval, auditing and compilation of Quality Technical Agreements • Implementation of investigations, Complaints and Recall system

• Evaluation of applications for authorization to import medicines through import permits and Section 75 • Evaluation of Donated products and import of such into Zimbabwe • New Inspections of premises such as Wholesalers, industrial clinics, Pharmacies, and Veterinary Surgeons • Routine Inspections of premises such as Wholesalers, industrial clinics, Pharmacies and Veterinary Surgeons • Receiving and evaluation of new premises application • Investigation of product-related and practice-related complaints • Public Inspection of Hospitals and Clinics under the MOHCC • Post Market surveillance of medicines distributed in Zimbabwe under UNICEF, UNDP through sampling and testing. • Building awareness of the safe and quality use of medicines in Zimbabwe through training ZRP police officers, CID and NPA • Conducting GMP inspections for new and already existing manufacturers. Conducted eleven (11) Indian Manufacturers GMP inspections and four (4) Zimbabwe Local manufacturers. • Risk assessment of product-related defects. • Physical Examination of medicines at the Robert Mugabe Airport