The Position:
The Quality Assurance Analyst position is within the Product Quality Assurance Team in the UNFPA Supply Chain Management Unit (SCMU). You report directly to the Quality Assurance Specialist. The position aims at provision of Quality Assurance services for Pharmaceuticals and Hormonal Contraceptives. The Quality Assurance Analyst will work closely with the new integrated HQ division (name To Be Decided), the UNFPA Supplies Partnership, the Humanitarian Response Division, other HQ Business Units, the Regional Offices, and the Country Offices and with the Supplier community.
The Product Quality Assurance Team is the life force of UNFPA's supplies, whereby the team ensures that contraceptives, medicines, medical devices, and kits UNFPA deliver to women and girls are safe, effective and will do no harm.
How you can make a difference:
UNFPA is the lead UN agency for delivering a world where every pregnancy is wanted, every childbirth is safe and every young person's potential is fulfilled. UNFPA’s strategic plan (2022-2025), reaffirms the relevance of the current strategic direction of UNFPA and focuses on three transformative results: to end preventable maternal deaths; end unmet need for family planning; and end gender-based violence and harmful practices. These results capture our strategic commitments on accelerating progress towards realizing the ICPD and SDGs in the Decade of Action leading up to 2030. Our strategic plan calls upon UN Member States, organizations and individuals to “build forward better”, while addressing the negative impacts of the Covid-19 pandemic on women’s and girls’ access to sexual and reproductive health and reproductive rights, recover lost gains and realize our goals.
In a world where fundamental human rights are at risk, we need principled and ethical staff, who embody these international norms and standards, and who will defend them courageously and with full conviction.
UNFPA is seeking candidates that transform, inspire and deliver high impact and sustained results; we need staff who are transparent, exceptional in how they manage the resources entrusted to them and who commit to deliver excellence in programme results.
Job Purpose:
As the Quality Assurance Analyst, you will support the Product Quality Assurance Team Lead’s efforts on the development and implementation of the Quality Assurance (QA) framework and policies for the management of sexual reproductive health commodities, coordinate QA activities for the whole of UNFPA, knowledge management, information sharing and manage partners’ relationships for quality assurance of health products, provides technical support to UNFPA Country Offices, Regional and HQ staffs in quality assurance related issues and; support innovation in Quality Assurance.
You would be responsible for:
You will support the Product Quality Assurance Team Lead’s efforts on:
A. Support the development and implementation of the QA framework and policies for the management of reproductive health commodities
- Analyze compliance of technical specifications of Pharmaceuticals and hormonal contraceptives and Emergency Reproductive Health (ERH) Kits.
- Manage risk management strategy in quality monitoring of Pharmaceuticals and hormonal contraceptives and Emergency Reproductive Health (ERH) Kits.
- Support the Product Quality Assurance Team Lead in the development, implementation, monitoring and reporting for UNFPA’s QA framework, policies, and related tools.
- Support the development and updates to the Quality Assurance Manual and any other related documents (SOPs, training materials, manuals, guidance materials) in collaboration with the relevant UNFPA units and in consultation with technical partners.
- Manage the annual quality assurance performance reviews of the suppliers and products in coordination with the other teams in SCMU.
- Monitor the quality of the health products, including quality testing reports, follow-up complaints, reassessment of sources.
- Provide inputs in the creation of specifications for RH commodities and other technical assignments for solicitation processes.
- Manages the system for Corrective and Preventive Actions (CAPA), complaints, non-conformances, and analyses of non-compliances. To include classification of complaints, completion of analyses, and failure analyses with thorough and effective documentation
- Monitors, performs, and documents sampling/testing and inspection of RH commodities and documents the results in compliance with cGDP, cGMP and UNFPA procedures.
- Contribute to quality assurance activities being appropriately documented and the development and maintenance of a record management system.
B. Coordination of Quality Assurance Team activities
- Establish relevant work plans and priorities, monitors achievements, and evaluates performance.
- Contribute to the recruitment processes for consultants and the maintenance of a roster of specialized consultants.
C. Support knowledge management, information sharing and partners’ relationships for quality assurance of health products
- Support the preparation of internal and external reports, including the annual reports.
- Facilitate the communication with other UNFPA business units, WHO, other UN agencies, the Global Fund, USAID, IPPF, MSI, PSI and others key actors for all technical matters related to quality assurance of RH commodities and MHM products.
- Support the Product Quality Assurance Team Lead in representing UNFPA in relevant technical meetings with partners, working groups and works towards harmonization and updates of the QA policy related to specifications and norms for medical devices.
- Contribute to information sharing on quality of sources and quality complaints with other agencies/partners at the global, regional, and local level.
- Participate in UNFPA and other relevant internal and external networks to promote the UNFPA QA Framework and its implementation in relevant forums (conferences, e-forum), and development and implementation of training plans.
- Collaborate with different stakeholders (UN agencies, other partner agencies, pharmaceuticals suppliers, manufacturers, technical experts, and testing laboratories) to ensure effective quality assurance of RH commodities and menstrual hygiene products.
D. Provide technical support to warehouse managers, UNFPA Country Offices, Regional and HQ staffs in quality assurance related issues
- Provide advice and guidance to UNFPA’s staff on issues related to the quality of health products and suppliers: review customers’ requirements and provides recommendations where appropriate.
- Support the identification of quality assurance issues, challenges, and risks and assists in providing constructive solutions including challenges in the handling of the health products at country level (e.g., storage and distribution); and
- Support the logistical management for UNFPA staff training and coordination and logistical support for events where the Procurement/Supply Coordinator is representing UNFPA, trainings, knowledge products and technical updates.
- Monitor, evaluate and assess the impact of an implemented temperature control and monitoring program for time and temperature sensitive health products (TTSHPs).
- Support the development of protocols and guidance documents for capacity strengthening of warehouse and supply chain managers.
E. Support Innovation in Quality Assurance
- Contribute to the creation and sharing of knowledge in implementing innovative approaches to QA activities.
- Perform trend and statistical analysis of test results and stability data from manufacturers to determine their Quality record.
- Development of new ways of monitoring quality of Pharmaceuticals and hormonal contraceptives and Emergency Reproductive Health (ERH) Kits.
- Contribute to the development and implementation of post-market surveillance and pharmacovigilance protocols for RH products.
F. Carry out any other duties as may be required by UNFPA SCMU leadership.
Qualifications and Experience:
Education:
- Advanced university degree required. An advanced university degree in Pharmacy, Pharmaceutical Sciences, Public Health, or related field is an advantage.
- Strong technical understanding of technical developments, industrial practices, and the pharmaceutical markets.
- Completion of relevant training, academic and/or professional certification in Quality Assurance and/or regulation of Pharmaceuticals or health products is an asset.
Knowledge and Experience:
- A minimum of 2 years of relevant professional relevant professional experience in pharmaceutical products, supporting program implementation and scale up of such products.
- Experience dealing with regulatory function, product manufacturing, quality assurance and quality control of pharmaceuticals or health products is required.
- Demonstrated knowledge of international markets (sources, certifications, and controls) is required.
- Technical knowledge of WHO standards and guidelines e.g., GDP, GMP, GLP etc is an asset.
- Work experience with the UN or an international organization is an asset.
- Work experience or support to developing countries is an asset.
- Experience in supervising staff is an asset.
- Excellent interpersonal, written, and oral communications skills.
Languages:
Fluency in English is required; knowledge of other official UN languages, preferably French and/or Spanish, is an asset.
Required Competencies:
Values:
- Exemplifying integrity,
- Demonstrating commitment to UNFPA and the UN system,
- Embracing cultural diversity,
- Embracing change
Core Competencies:
- Achieving results,
- Being accountable,
- Developing and applying professional expertise/business acumen,
- Thinking analytically and strategically,
- Working in teams/managing ourselves and our relationships,
- Communicating for impact
Functional Competencies:
- Effective application of health supply-chain management frameworks, principles, and processes
- Effective management of risks in line with relevant industry standards, frameworks, and processes.
- Ability to analyse issues, applying sound technical principles, data, and informed professional judgement, and to present solution alternatives with a clear articulation of their risks and consequences.
- Ability to communicate effectively in writing and verbally.
- Planning and organising
- Strong client service orientation.
Compensation and Benefits:
This position offers an attractive remuneration package including a competitive net salary plus health insurance and other benefits as applicable.
Disclaimer:
UNFPA does not charge any application, processing, training, interviewing, testing or other fee in connection with the application or recruitment process. Fraudulent notices, letters or offers may be submitted to the UNFPA fraud hotline http://www.unfpa.org/help/hotline.cfm
In accordance with the Staff Regulations and Rules of the United Nations, persons applying to posts in the international Professional category, who hold permanent resident status in a country other than their country of nationality, may be required to renounce such status upon their appointment.
We are no longer accepting applications for this position.
