AUDA-NEPAD

REQUEST FOR EXPRESSIONS OF INTEREST (REOI) FOR INDIVIDUAL CONSULTANTS
Title: Consultancy to Design and Establish a Quality Management System (QMS) for the
African Union Smart Safety Surveillance (AU-3S) Programme.
PROCUREMENT NUMBER: 140/DHCID/AU-3S/ICS/2025
Method: Individual Consultants Selection (ICS) - Individuals Only
1. INTRODUCTION
Background and Context
The African Union Smart Safety Surveillance (AU-3S) Programme, coordinated by the African
Union Development Agency-New Partnership for Africa's Development (AUDA-NEPAD), is a
flagship initiative aimed at strengthening regulatory systems across African Union (AU) Member

States. The programme was established as a continental response to the growing need for fit-
for-purpose, African-led pharmacovigilance systems that ensure the safety of medical products

throughout their lifecycle.
AU-3S employs a coordinated, risk-based approach grounded on the principles of the "smart"
concept—pilot implementation, scalability, work-sharing, data aggregation, prioritization, and
regulatory reliance. It supports member states in strengthening national safety surveillance

capacities by leveraging digital tools, enhancing signal management, promoting country-to-
country collaboration, and establishing partnerships that span from clinical trials to post-market

monitoring.
As AU-3S expands its scope and deepens partnerships across the continent, it recognizes that
strengthening pharmacovigilance and safety surveillance requires more than technical
expertise. It demands clearly defined structures, sustainable processes, and a culture of quality,
transparency, and accountability.
In this context, AUDA-NEPAD is initiating the development of a comprehensive Quality
Management System (QMS) for the AU-3S Programme and its core deliverables. The QMS will
offer a systematic framework to standardize internal processes, improve operational efficiency,
and ensure the consistent and high-quality delivery of programme activities. It will enable
effective documentation, performance tracking, risk-informed planning, and continuous
improvement—core elements of good governance and sustainability.
By aligning the QMS with international standards such as ISO 9001:2015, ISO31000:2018
requirements, AUDA-NEPAD aims to enhance institutional transparency, foster stakeholder
confidence, and reinforce the AU-3S Programme as a credible, regional model for regulatory
system strengthening. The QMS will further support evidence-based decision-making,
regulatory systems strengthening, and accountability in safety surveillance implementation.
This initiative represents a strategic investment in embedding quality at the heart of AU-3S
operations, thereby reinforcing the programme’s relevance, resilience, and impact within Africa’s
evolving health landscape.
2. SCOPE/MAIN RESPONSIBILITIES OF THE ASSIGNMENT
The Consultant shall deliver on the following tasks:
1. Situational Analysis and Process Mapping
➢ Conduct a comprehensive review of existing AU-3S programme processes including its
main workstreams, tools, SOPs, and reporting frameworks.

➢ Identify strengths, weaknesses, and gaps related to current quality management
practices.
➢ Map core and support processes critical to AU-3S implementation, coordination, and
oversight.
2. QMS Framework Design
➢ Design a fit-for-purpose QMS framework aligned with ISO 9001:2015 standards and
adapted to the AU-3S context.
➢ Develop and/or update key QMS documentation, including:
▪ Quality Manual
▪ Quality Policy and Quality Objectives
▪ Standard Operating Procedures (SOPs)
▪ Workflows and process maps
▪ Templates, forms, and checklists for quality monitoring
▪ Internal audit and non-conformity reporting templates

3. Stakeholder Engagement and Capacity Building
➢ Facilitate stakeholder consultations to ensure the QMS reflects the operational realities
and needs of AUDA-NEPAD and AU-3S implementing partners.
➢ Conduct training sessions and workshops for AUDA-NEPAD staff and focal points on
QMS principles, procedures, and implementation requirements.
➢ Develop user-friendly training materials and implementation guides to support ongoing
QMS usage.
4. QMS Implementation Planning
➢ Develop a detailed implementation roadmap, including timelines, responsible parties,
and key milestones.
➢ Define quality performance indicators and develop a monitoring and evaluation
mechanism to track QMS effectiveness across all workstreams.
➢ Recommend digital tools or systems to support QMS implementation and data
management.
5. Continuous Improvement and Readiness for Audit
➢ Design a framework for periodic review and continuous improvement of the QMS.
➢ Support the AU-3S team in preparing for internal and/or external quality audits, if
applicable.
➢ Provide technical guidance on sustaining the QMS, including options for long-term quality
assurance and certification readiness.
6. Reporting and Knowledge Transfer
➢ Submit a comprehensive final report detailing all processes, tools developed, training
delivered, and recommendations for sustainability.
➢ Ensure full knowledge transfer to AUDA-NEPAD technical teams to facilitate continued
ownership and maintenance of the QMS

3. DELIVERABLES
The consultant is expected to deliver a fit-for-purpose QMS for the AU-3S Programme, aligned
with international standards such as ISO 9001:2015.
The Consultant is expected to deliver the following:
3.1 Result 1: Inception report
3.2 Result 2: Gap assessment report providing analysis of existing quality
management practices, identification of gaps, and recommendations

3.3 Result 3: Draft QMS framework and SOPs
3.4 Result 4: Report on stakeholder consultation and validation of the draft QMS
3.5 Result 5: Final QMS package aligned with ISO 9001:2015, including
implementation plan
3.6 Result 6: End-of-assignment report summarizing activities, outcomes, challenges,
and recommendations
4. AUDA-NEPAD now invites eligible individual consultants (“Consultants”) to indicate their
interest in providing the Services. Interested Consultants should provide information
demonstrating that they have the required qualifications and relevant experience to perform
the Services.
5. QUALIFICATIONS, EXPERIENCE AND COMPETENCIES
Qualifications
• A University Bachelor’s degree in Social Sciences, Communication, Monitoring &
Evaluation, Public Relations, Business Administration and Management,
Sociology, Project Management, International Relations, Development Studies,
Finance, Computer Science, Mathematics, Health Sciences, Agriculture, Food
Science and Technology or related fields with 3 years of progressive professional
experience in Public Health or Institutional Development or Social Development
within the public sector institutions or similar organisations nationally, regionally,
and/or continentally. Advanced qualifications (Master’s or PhD) is an added
advantage.
Experience
• At least 10 years of relevant professional experience, including a minimum of 5 years
in quality management systems design, implementation, and evaluation, preferably
in the context of health regulatory systems or public health institutions.
• Demonstrable experience in establishing and operationalizing QMS in a national or
multinational regulatory authority or equivalent institution is highly desirable.
• Strong knowledge and practical application of international QMS standards,
particularly ISO 9001:2015.
• Proven ability to assess organizational processes, identify gaps, and develop
standard operating procedures and implementation frameworks.
• Experience working with multi-stakeholder initiatives and regional programmes,
ideally in Africa or similar contexts.
• Excellent analytical, writing, and communication skills, with the ability to engage
diverse stakeholders and facilitate technical discussions effectively. Familiarity with
the African regulatory landscape and institutional structures within the African Union
is an added advantage.
6. SHORTLISTING CRITERIA
For evaluation of the expressions of interest, the following criteria will be applied:
a. Qualifications - Education and Relevant Training (30 points);
b. Experience related to the Assignment (40 points);
c. Similar previous experience related to the Assignment (20 points); and
d. Knowledge and experience of the region & local conditions (10 points).
A Consultant will be selected in accordance with Individual Consultant Selection (ICS) method
set out in the AU Procurement Manual. TORs are attached as annex 1
7. SUBMISSION REQUIREMENTS
Interested candidates are requested to submit the following documents for AUDA-NEPAD
consideration:
I. Cover letter confirming compliance to eligibility.
II. Signed declaration of undertaking (attached as Annex 1 below);
III. Curriculum Vitae (CV); and

IV. Proof of stated qualifications in the form of the copies of the degrees obtained.
8. TIME FRAME FOR THE ASSIGNMENT:
The consultancy will be for a period of 6 months.
9. Only Individual Consultants are eligible for this assignment if they fulfil the following
eligibility criteria:
a) Have no conflict of interest in relationship to performance of this assignment;
b) Are not subject to, and not controlled by any entity or individual that is subject to, a
temporary suspension or a debarment imposed by the African Union Commission, World
Bank or any other multilateral development bank and being listed on the website
http://www.worldbank.org/debarr or respectively on the relevant list of any other
multilateral development bank. Further, are not ineligible pursuant to a decision of the
United Nations Security Council.
c) Have not been convicted by a final judgement or a final administrative decision or subject
to financial sanctions by the United Nations or Country for involvement in a criminal
organisation, money laundering, terrorist-related offences, child labour or trafficking in
human beings; this criterion of exclusion is also applicable to legal Persons, whose
majority of shares are held or factually controlled by natural or legal Persons which
themselves are subject to such convictions or sanctions;
d) Are not being bankrupt, wound up or ceasing our activities, having our activities
administered by courts, having entered receivership, reorganisation or being in any
analogous situation;
e) Are not involved in corruption: offering, giving, receiving or soliciting, directly or indirectly,
anything of value to influence improperly the actions of another party;
f) They have not been the subject of a judgment which has the force of res judicata for
fraud, corruption, involvement in a criminal organization or any other illegal activity
detrimental to the AUDA-NEPAD financial interests;
g) they have not been declared guilty of gross professional misconduct proven by any
means which AUDA-NEPAD can justify;
h) Comply with their national tax and social security laws
Interested consultants may obtain further information from the address listed below. All
Expression of Interests should be sent electronically to email listed below.
10. Expressions of interest must be delivered to the address below by email on or before 29th
August 2025 14:30 hours (South African Time). All EOI’s must be marked “Consultancy
to Design and Establish a Quality Management System (QMS) for the African Union
Smart Safety Surveillance (AU-3S) Programme: Procurement Reference no.
140/DHCID/AU-3S/ICS/2025 –in the subject line of the email.
11. Privacy Policy: AUDA-NEPAD Procurement office collects and uses your personal
information for “Procurement Process” when you intend to compete and deliver any
service or goods for the organization either individually or as a firm based on your
consent. Your personal data is our highest security and kept for a period strictly
necessary for the purpose set out. This privacy notice supplements the AUDA-NEPAD
standard privacy notice and should be read in conjunction with the same available on
AUDA-NEPAD website.
12. All Interested bidders may attend the bid opening online by joining via the below link at 14:40
hours South African Time.
Bid opening meeting link

The Chairperson Internal Procurement Committee (IPC)

AUDA-NEPAD

230, 15th Road, P. O. Box 218 Midrand,
1685 Johannesburg, South Africa

Email: [email protected] & copy [email protected]
Attention of: Head of Procurement Division