Quality Assurance Associate

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Description

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UNFPA occupies a unique position in the sexual and reproductive health commodity ecosystem as a critical player in supply chain management, a leading public procurer of sexual and reproductive health commodities, a trusted partner to national governments, and one of the few organizations with the scale and partnerships necessary to build accountability for last mile delivery. 

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. 

Job Purpose:

As the Quality Assurance Associate, you will 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, coordinate Product Quality Assurance activities for the whole of UNFPA, knowledge management, information sharing and maintain 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.

Main Task and Responsibilities:

You will support the Product Quality Assurance Team Lead’s efforts on:

Oversee UNFPA’s Product Quality Assurance Team on: 

• 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 program.
• Assist in analysing and handling deviations of transportation and storage conditions.
• Tracks and manages 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.
• Monitors, performs, and documents sampling/testing and inspection of RH medicine or medical devices samples and documents the results in compliance with cGDP, cGMP and UNFPA procedures.
• Maintains 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.

Capacity Strengthening:

• Support the implementation of UNFPA’s capacity-strengthening initiatives.
• Train supply chain professionals whenever possible and support their development through sharing knowledge and experience.

Thought Leadership, Knowledge Sharing and Advisory:

• Appreciate UNFPA’s supply chain thought leadership through awareness and incorporating such initiatives into the overall approach to day-to-day activities. 
• Actively contribute to an environment of knowledge retention and sharing by following best practices for supply chain implementation.
• Support improved supply chain execution by incorporating best practices and continuous improvement into day-to-day activities.  

Partnerships and Resource Mobilization:

• Support UNFPA’s value proposition and relationships with donors and partners.
• Assist with the preparation of SCMU’s resource mobilization proposals in particular with data and analysis.

Collaboration and Representation:

• Maintain effective collaboration with relevant stakeholders within UNFPA to ensure coordinated and effective tailored solutions for each area of intervention.
• Maintain relationships with supply chain counterparts with the purpose of increasing the efficiency of UNFPA’s supply chain function.
• Attend and participate as required in SCMU and UNFPA in meetings related to supply chain management functions.
• Carry out any other duties as may be required by the Chief, SCMU.

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; knowledge of other official UN languages is an asset.

Source: https://www.unfpa.org/jobs/re-advertisement-quality-assurance-associate-supply-chain-management-unit-scmu-copenhagen

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