Consultancy, Quality Assurance Associate, Supply Chain Management Unit (SCMU), Copenhagen, Denmark, Copenhagen

Job Purpose:

The purpose of this consultancy is to support the Product Quality Assurance Team Lead’s efforts on the development and implementation of the Product Quality Assurance framework and policies for the supply of sexual reproductive health commodities, and managing quality risk through complaint logging, regulatory alert responses, and vendor compliance reporting. Key technical tasks include managing CAPA systems, handling deviations in transportation or storage, and performing product sampling and inspections in accordance with current Good Distribution Practice (cGDP) and the current Good Manufacturing Practice (cGMP) standards. Additionally, the consultant is expected to maintain product recall and quarantine systems, prepare quality metrics, and collaborate with international stakeholders such as WHO and UNICEF. The role also supports UNFPA's capacity-strengthening initiatives by supporting the training of supply chain professionals in the cGDP and sharing technical expertise. The consultant will report directly to the Quality Assurance Analyst in the Product Quality Assurance team in Pillar 3 of the Supply Chain Management Unit (SCMU).

How you can make a difference:

UNFPA is the lead United Nations agency for delivering a world where every pregnancy is intended, every childbirth is safe, and every young person's potential is fulfilled. The UNFPA Strategic Plan for Se telefonnummer på uncareer.net articulates the organization’s response to a complex global environment, providing a roadmap for resilience and renewal. It is designed to accelerate the implementation of the Programme of Action of the International Conference on Population and Development (ICPD) and the achievement of the Sustainable Development Goals by 2030. This mandate is pursued through a focus on four interconnected outcomes: ending the unmet need for family planning; ending preventable maternal deaths; ending gender-based violence and harmful practices; and adapting to demographic change through evidence and rights-based policies. 
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.

The UNFPA Supply Chain Management Unit (SCMU) is self-funded and was made operational in January 2022. It is tasked with ensuring that UNFPA is able to effectively and efficiently support the delivery of life-saving reproductive health products and other programme supplies to the end user when and where they are needed. To achieve this, it is important to strengthen the capacity of governments and implementing partners to ensure coordination, end-to-end visibility and accountability on all supply chain and logistics management related activities, in particular for programme supplies, across all UNFPA programmes.

UNFPA is seeking candidates who transform, inspire, and deliver high-impact and sustained results and ensure effective external relations, communications, and partnership-building and resource mobilization in a rapidly changing development and funding landscape. We need staff who are transparent, exceptional in how they manage the resources entrusted to them, and who commit to delivering excellence in programme results.

You would be responsible for:

Apply risk management strategy to quality complaints and responses to regulatory quality alerts/notices of concern and maintain the quality complaints log. Generate reports on compliance of suppliers to technical specifications in support of vendor qualification programs. Assist in analysing and handling deviations of transportation and storage conditions. Track and manage the system for CAPAs, complaints, non-conformances, and analyses of non-compliances. To include classification of complaints, completion of analyses, and failure analyses with thorough and effective documentation. Perform and support maintenance and closure of activities of documents such as reports, exceptions/deviations and change controls. Monitor, perform, and document sampling/testing and inspection of RH medicine or medical devices samples and documents the results in compliance with cGDP, cGMP and UNFPA procedures. Maintain quarantine/release/reject system for Pharmaceuticals and hormonal contraceptives and Emergency Reproductive Health (ERH) Kits. Maintain a robust product recall system and work with all stakeholders to effectively manage a recall. Track, trend, and prepare quality metrics. Review terms of references for Product Quality Assurance services e.g., inspection, testing services and perform technical evaluation of the same. Collaborate with different stakeholders (WHO, UNICEF, other partner agencies, pharmaceuticals suppliers, manufacturers, technical experts, and testing laboratories) to ensure effective quality assurance of RH medicines. Participate in Product Quality Assurance Team meetings and present deliverable outputs. Minor financial activities such as budget management may be required. Apply risk-based approach during management of deviations during pre-shipment inspections. Contribute to the creation and sharing of knowledge in implementing innovative approaches to UNFPA's Product Quality Assurance activities when it comes to technical inputs. Development and updating of standard operating procedures to ensure compliance of Product Quality Assurance activities from technical side to UNFPA's Quality Assurance framework. Support and implement activities related to UNFPA’s Governance, Risk, Compliance and Reporting function.

Qualifications and Experience: 

Education:  

Completion of Secondary education is required. University degree in Pharmacy, Pharmaceutical Sciences, Material Science, Medical Laboratory Science/Technology, Nursing, Biomedical Sciences, Public Health, or related field would be an asset Completion of relevant training, academic and/or professional certification in Quality Assurance of health products is an asset.

Knowledge and Experience: 

Minimum 6 years of related work experience in quality assurance or product development or quality control of pharmaceuticals, or sterile health products or regulatory authority experience of medical devices/health products or health technologies is required. Proven analytical and technical knowledge of reproductive health products is a strong advantage. Knowledge of reproductive health commodities and medical terminology is a strong advantage. Experience in coordination of workshops is desirable. Demonstrated knowledge of international markets (sources, certifications, and controls) 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. Excellent interpersonal, written, and oral communications skills; team management skills is an asset

Languages: 

Fluency in English is required. Working knowledge of another official UN language 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,

UNFPA Work Environment:

UNFPA provides a work environment that reflects the values of gender equality, diversity, integrity and healthy work-life balance. We are committed to ensuring gender parity in the organization and therefore encourage women to apply. Individuals from the LGBTQIA+ community, minority ethnic groups, indigenous populations, persons with disabilities, and other underrepresented groups are highly encouraged to apply. Reasonable accommodation may be provided to applicants with disabilities upon request, to support their participation in the recruitment process. UNFPA promotes equal opportunities in terms of appointment, training, compensation and selection for all regardless of personal characteristics and dimensions of diversity. Diversity, Equity and Inclusion is at the heart of UNFPA's workforce - click here to learn more.

Disclaimer:

Selection and appointment may be subject to background and reference checks, medical clearance, visa issuance and other administrative requirements. 

UNFPA does not charge any application, processing, training, interviewing, testing or other fee in connection with the application or recruitment process and does not concern itself with information on applicants' bank accounts. 

Applicants for positions in the international Professional and higher categories, who hold permanent resident status in a country other than their country of nationality, may be required to renounce such status upon their appointment.