Title: International Good Manufacturing Pharmaceutical practices (GMP) Expert

​​Requisition ID: 4328
Grade: ISA-Specialist
Country: Home Based
Duty Station: Home Based
Category: International Consultant
Type of Job Posting: Internal and External
Employment Type: Non-staff WAE
Contract Duration: 55 working days over a period
Application Deadline: 22-Aug-2024, 11:59 PM (CEST)

Vacancy Announcement
TEMPORARY APPOINTMENT OF PROJECT PERSONNEL
Female candidates are encouraged to apply.

ORGANIZATIONAL CONTEXT

The United Nations Industrial Development Organization (UNIDO) is the specialized agency of the United Nations that promotes industrial development for poverty reduction, inclusive globalization and environmental sustainability. The mission of UNIDO, as described in the Lima Declaration adopted at the fifteenth session of the UNIDO General Conference in 2013 as well as the Abu Dhabi Declaration adopted at the eighteenth session of UNIDO General Conference in 2019, is to promote and accelerate inclusive and sustainable industrial development (ISID) in Member States. The relevance of ISID as an integrated approach to all three pillars of sustainable development is recognized by the 2030 Agenda for Sustainable Development and the related Sustainable Development Goals (SDGs), which will frame United Nations and country efforts towards sustainable development. UNIDO’s mandate is fully recognized in SDG-9, which calls to “Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation”. The relevance of ISID, however, applies in greater or lesser extent to all SDGs. Accordingly, the Organization’s programmatic focus is structured in four strategic priorities: Creating shared prosperity; Advancing economic competitiveness; Safeguarding the environment; and Strengthening knowledge and institutions.

Each of these programmatic fields of activity contains a number of individual programmes, which are implemented in a holistic manner to achieve effective outcomes and impacts through UNIDO’s four enabling functions: (i) technical cooperation; (ii) analytical and research functions and policy advisory services; (iii) normative functions and standards and quality-related activities; and (iv) convening and partnerships for knowledge transfer, networking and industrial cooperation. Such core functions are carried out in Divisions/Offices in its Headquarters, Regional Offices and Hubs and Country Offices.

Under the overall direction of the Director General, and in close collaboration with all relevant organizational entities within UNIDO, the Directorate of Technical Cooperation and Sustainable Industrial Development (TCS), headed by a Managing Director, ensures the Organization’s application of strategies and interventions for sustainable industrial development related to environment, energy, Micro, Small and Medium-Enterprises (MSMEs), and digitalization. The Directorate also oversees the Organization’s normative contribution to achieving the Sustainable Development Goals through industrial policy advice and capacity development. Through coordination in-house and with Member States and industry stakeholders, it ensures that the services provided in these areas contribute to effective and appropriate technical, business and policy solutions and are focused on results, scaling up and positioning UNIDO as a leading platform for industrial development in developing countries and global fora.

The Directorate is responsible for the Division of Industrial Policy Advice and Capacity Development (TCS/IPC), and technical Divisions of Circular Economy and Green Industry (TCS/CEG), Energy and Climate Action (TCS/ECA), Climate Innovation and Montreal Protocol (TCS/CMP); MSME Competitiveness, Quality and Job Creation (TCS/SME); and Digital Transformation and Artificial Intelligence (TCS/DAI). Leveraging the diverse skill sets of UNIDO personnel and the services provided by the two TC directorates, TCS collaborates closely with IET to develop and implement programmes and projects, aiming at enhancing synergy and complementarity and maximizing UNIDO corporate performance and impacts on the ground. The Directorate also ensures close coordination and collaboration among the Divisions as well as with relevant entities in all Directorates across the Organization.

The Division of MSME Competitiveness, Quality and Job Creation (TCS/SME) works towards increasing the competitiveness of industries in developing countries and countries in transition, especially emphasizing business development of MSMEs engaged in manufacturing and creating jobs therein. It aims at increasing competitiveness among MSMEs in two interconnected ways: first, by modernizing businesses through the transfer of advanced technologies adapted to local conditions, product innovation, productivity improvement and upgrading, developing market and value chain readiness as well as improved access to finance; and second, by improving the quality of MSME manufactured products and their compliance with market requirements through capacity building for the development of industrial production and trade-related quality infrastructure including for standardization, metrology, accreditation and of conformity assessment service institutions (testing, certification, inspection and calibration) and the strengthening of their capacities.

This position is located under the MSME Development and Job Creation Unit (TCS/SME/MDJ) that supports small and medium manufacturing enterprises (SMEs) in Member States to take advantage of new technologies, business and organizational support, investment promotion, cluster development and partnerships to improve their businesses and improve their competitiveness.

The incumbent works under the overall guidance of the Division Chief and the direct supervision of the Industrial Development Officer serving as Team Lead for Health Industries and managing the UNIDO project “Strengthening the production of vaccines and pharmaceuticals in Senegal” (ID: 230283), which is funding this position.

PROJECT CONTEXT

The aim of the project “Strengthening the production of vaccines and pharmaceuticals in Senegal” (UNIDO ID 230283) is to enhance the capacity of Senegalese manufacturing companies, including local pharmaceutical manufacturers and Institut Pasteur de Dakar, to produce quality-assured essential medicines and vaccines, reduce compliance on imports and improve access to regional population to pharmaceutical products.

UNIDO will bring its decades-long experience to bear in Senegal, initially in conducting comprehensive baseline ecosystem assessments of the national pharmaceutical industry, including the policy framework, incentives, infrastructure, regulatory and procurement systems, to identify strengths, weaknesses, opportunities, and threats. The assessments will help the country gain a better and more nuanced understanding of the sector’s status, market dynamics, regulatory frameworks, and technological capabilities. UNIDO will specifically use its considerable convening power and proven ability to foster linkages between the various stakeholders from the public and private sector, global public health institutions, financing institutions, global regulatory bodies, mature industries in the developed world, and academia.

The main target groups for this project are public institutions such as the Delivery Unit and SMEs from Senegal associated with the pharmaceutical manufacturing ecosystem. UNIDO’s interventions are based on a systemic and holistic approach that involves all key stakeholders, from policymakers, regulators, industry, to market intelligence companies, multi-lateral organizations and technical partners, and donors. The project will aim to coordinate the activities of different players at national, regional, and continental levels. Specifically, UNIDO will support the DU in mobilizing and aligning inter-ministerial coordination between, for example, finance, health, trade, and industry as a crucial intervention in Senegal.

The main project counterparts are the Pharmaceutical Delivery Unit (DU) of MSAS, National Regulatory Agency (ARP), National Supply Pharmacy (SEN-PNA), National Association of Pharmaceutical Manufacturers (ASIP).

FUNCTIONAL RESPONSIBILITIES

Under the close supervision of the Project Manager and the project team, the International Expert shall fulfil the following duties:

1. Guideline and Strategy Development: Develop a comprehensive guideline and strategy, including a step-by-step assessment tool for evaluating and integrating best practices in pharmaceutical manufacturing.

2. HOW TO OPERATIONALIZE GMP ROADMAP – Assess Pharma companies’ compliance to GMP and support their access to leveraged experience and implementing the GMP practices in their facilities.

3. Focus Areas: Concentrate on regulatory compliance and laboratory practices, emphasizing identifying opportunities for diversification in the pharmaceutical sector.

4. Assessment Focus Areas: Assess 4 key areas:

• Organizational: HR, skills development, and workforce optimization.

• Regulatory: Compliance, regulatory frameworks, and quality assurance.

• Production: Efficiency, innovation in production processes, and lean manufacturing practices.

• Opportunities: Product diversification, market access, and investment opportunities.

5. Integration Guide: Develop a detailed, step-by-step guide for assessing and integrating improvements in the identified focus areas.

6. Training and Workshops: Conduct trainings and workshops for participants from private sector companies in Senegal.

7. Stakeholder Engagement: Actively participate in discussions and engage with public and private sector stakeholders in Senegal.

MINIMUM ORGANIZATIONAL REQUIREMENTS

Education: Advanced degree in Pharmaceutical Sciences, Engineering, or a related field.

Proven experience in pharmaceutical manufacturing and regulatory environments.

The expert must be Six Sigma certified and proficient in lean manufacturing, Six Sigma, Kaizen, and circular economy principles, specifically applied to the health industry.

Experience, technical and functional expertise

• A minimum of 7 years of professional experience, including some at the international level, in managing GMP implementation processes and conducting GMP compliance assessments in the pharmaceutical sector is required.

• The expert must be Six Sigma certified and proficient in lean manufacturing, Six Sigma, Kaizen, and circular economy principles, specifically applied to pharmaceutical manufacturing.

• Experience working with various stakeholders in the pharmaceutical industry, including companies, government agencies, and international organizations, with knowledge of their operational models, market dynamics, and regulatory environments, is required.

• Demonstrated experience in GMP compliance, regulatory frameworks and the best practices within the pharmaceutical sector

• Experience working in or with developing countries, particularly in Africa, is highly desirable.

• Demonstrated ability to author publications and research reports on GMP, pharmaceutical manufacturing, and regulatory compliance, with experience in preparing strategic documents for international organizations, companies, and government agencies, is required.

• Demonstrated ability to conduct trainings and workshops for participants from private sector companies, focusing on best practices in pharmaceutical manufacturing and regulatory compliance while providing comprehensive training materials is required.

Languages: Fluency in written and spoken English and French is required.

REQUIRED COMPETENCIES

Core Values

WE LIVE AND ACT WITH INTEGRITY: work honestly, openly and impartially.

WE SHOW PROFESSIONALISM: work hard and competently in a committed and responsible manner.

WE RESPECT DIVERSITY: work together effectively, respectfully and inclusively, regardless of our differences in culture and perspective.

Key Competencies

WE FOCUS ON PEOPLE: cooperate to fully reach our potential –and this is true for our colleagues as well as our clients. Emotional intelligence and receptiveness are vital parts of our UNIDO identity. WE FOCUS ON RESULTS AND RESPONSIBILITIES: focus on planning, organizing and managing our work effectively and efficiently. We are responsible and accountable for achieving our results and meeting our performance standards. This accountability does not end with our colleagues and supervisors, but we also owe it to those we serve and who have trusted us to contribute to a better, safer and healthier world.

WE COMMUNICATE AND EARN TRUST: communicate effectively with one another and build an environment of trust where we can all excel in our work.

WE THINK OUTSIDE THE BOX AND INNOVATE: To stay relevant, we continuously improve, support innovation, share our knowledge and skills, and learn from one another.

This appointment is limited to the specified project(s) only and does not carry any expectation of renewal.
Employees of UNIDO are expected at all times to uphold the highest standards of integrity, professionalism and respect for diversity, both at work and outside. Only persons who fully and unconditionally commit to these values should consider applying for jobs at UNIDO.

All applications must be submitted online through the Online Recruitment System. Correspondence will be undertaken only with candidates who are being considered at an advanced phase of the selection process. Selected candidate(s) may be required to disclose to the Director General the nature and scope of financial and other personal interests and assets in respect of themselves, their spouses and dependents, under the procedures established by the Director General.

Visit the UNIDO website for details on how to apply: www.unido.org

NOTE: The Director General retains the discretion to make an appointment to this post at a lower level.

Notice to applicants:
UNIDO does not charge any application, processing, training, interviewing, testing or other fee in connection with the application or recruitment process. If you have received a solicitation for the payment of a fee, please disregard it. Vacant positions within UNIDO are advertised on the official UNIDO website. Should you have any questions concerning persons or companies claiming to be recruiting on behalf of UNIDO and requesting payment of a fee, please contact: [email protected]