MANDISA SKHOSANA

SAHPRA’S CORE BUSINESS:

SAHPRA is an entity of the National Department of Health, created by the South African Government to ensure that the health and well-being of human and animal health are at its core.

SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics (IVDs). Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).

• Serving in the Technical Oversight and Research Strategy Committee
• The Committee is primarily responsible for advising the Board on the operational transformation and regulatory strategic development of SAHPRA in order to meet its statutory obligations.
• Review, evaluate and advise the Board regarding the short-, medium-, and long- term goals and objectives of SAHPRA, including the gaps and progress against defined goals and objectives.
• Monitor and evaluate trends in regulatory sciences and recommend to the Board emerging technologies and approaches for building the Authority’s capacity
• Assist the Board in establishing and the Authority in implementing the technical and operational strategy and direction within the context of the overall SAHPRA organizational plan.
• Oversee the implementation of appropriate procedures, processes and systems to support the registration, regulation and control of all health products based on current international best practice standards and national conditions and needs.
• Collaborate with other government departments in achieving strategic economic and social imperatives for South Africa and the region.

ICAP was founded at Columbia’s Mailman School of Public Health in 2003 by Wafaa El-Sadr. ICAP was created at a time when an estimated 2.4 million people were dying every year from HIV around the world. As the global crisis unfolded, ICAP was determined to overcome the challenge of making HIV treatment available in areas with very limited health care infrastructure.

Based at Columbia University with operations in more than 30 countries, ICAP is a leader in global public health, internationally known for tackling the world’s toughest health challenges—from HIV to tuberculosis, from malaria to maternal and child health, and the growing problem of non-communicable diseases, and most recently, the COVID-19 pandemic. Through innovative research, collaborative technical assistance, and a focus on strengthening health systems, ICAP helps to create better, more accessible, health services to reduce the burden of illness on people and communities.

Duties

• Supporting the implementation of a laboratory agenda in ICAP's Population-Based HIV Impact Assessment (PHIA) survey in the implementing countries (Lesotho, Zimbabwe, Eswatini, Mozambique, Uganda, Malawi) by:
• Assisting with country level laboratory assessments to identify suitable sites to be used as satellite laboratories
• Strengthening country laboratory networks through capacity building and quality management systems
• Supporting biomarker training, conducting monitoring visits and Supporting the implementation of laboratory procedures and activities for the PHIA survey
• Document review
• Drafting SOPs

Quest Africa Diagnostics is a privately owned diagnostic laboratory provide routine laboratory tests to medical practitioners to aid in diagnoses of diseases.

Duties:

• Co-managing all aspects of the business
• Technical and QC Oversight
• Operations Management
• Financial Management
• Human Resource Management
• Logistical Management
• Business Development
• Education and Training

• ZG Training and Development,
• Community and Stakeholder engagement
• Project Management
• Community mobilization.
• Collected data on program efficacy through data analysis and implemented solutions for improvement.
• Planned and facilitated workshops in accordance with curricula, employing varied methods to maximize attendance.
• Identified areas in need of improvement and implemented solutions.

The South African Medical Research Council (SAMRC) was established in 1969 with a mandate to improve the health of the country’s population, through research, development and technology transfer, so that people can enjoy a better quality of life. The scope of the organisation’s research projects includes tuberculosis, HIV/AIDS, cardiovascular and non-communicable diseases, gender and health, and alcohol and other drug abuse. With a strategic objective to help strengthen the health systems of the country – in line with that of the Department of Health, the SAMRC constantly identifies the main causes of death in South Africa.

Duties

• Managing all activities related to the implementation of various research projects in the field of HIV prevention. My duties included
• Staff and resource management
• Contributing to the development of research protocol and adaptation of procedures to suit the various clinical sites
• Training of research site staff on the protocol
• Performance management of staff
• Ensuring that recruitment and retention targets are met
• Performing quality control of research data and ensuring that data is collected as per research protocol requirements.

• On-site laboratory testing for HIV and STI’s
• Laboratory Quality Control
• Stock Control
• Outsourcing management
• Report Writing
• Training of new staff

• Microbiological Investigation of transfusion reactions
• Infection Control in Donor areas
• Report Writing
• Conducted data review and followed standard practices to find solutions.
• Suggested improvements to designs and documentation to improve product reliability and manufacturability.
• Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.

NBI is a private, non-profit, pharmaceutical manufacturer of human plasma-derived medicinal products, including clotting factors, immunoglobulins, albumin solutions and solvent detergent treated dried plasma.

NBI's comprehensive range of plasma-derived medicinal products are registered with the South African Regulatory Authority (SAHPRA)

Duties

• Quality control of raw material, in-process, and final pharmaceutical products.
• Microbiological assessment of manufacturing and filling areas.
• Preparation and Quality control of culture media.
• Chemical analyses of in-process products e.g protein electrophoresis, pH measurements.

• Experiential training in Biochemistry, Haematology, Seroroly, Immunology and Microbiology.
• Passed the professional board examination in 1999 in the Clinical Pathology discipline.