Consultant for Product Quality Assurance

Job Posting Organization:
The United Nations Population Fund (UNFPA) is the lead UN agency focused on reproductive health and rights, aiming to ensure that every pregnancy is intended, every childbirth is safe, and every young person's potential is fulfilled. Established in 1969, UNFPA operates in over 150 countries, employing approximately 4,000 staff members. The organization is dedicated to advancing the goals of the International Conference on Population and Development (ICPD) and the Sustainable Development Goals (SDGs) by 203

• UNFPA's mission is pursued through a focus on four interconnected outcomes: ending unmet needs for family planning, preventing maternal deaths, eliminating gender-based violence, and adapting to demographic changes through evidence-based policies. The Supply Chain Management Unit (SCMU) was operationalized in January 2022 and is self-funded, tasked with ensuring the effective delivery of life-saving reproductive health products and supplies.

Job Overview:
The consultant will play a crucial role in supporting the Product Quality Assurance Team Lead in developing and implementing a comprehensive Product Quality Assurance framework and policies specifically for the supply of sexual reproductive health commodities. This position involves managing quality risks through various means, including complaint logging, responding to regulatory alerts, and ensuring vendor compliance reporting. Key technical tasks include managing Corrective and Preventive Action (CAPA) systems, addressing deviations in transportation or storage conditions, and conducting product sampling and inspections in line with current Good Distribution Practice (cGDP) and current Good Manufacturing Practice (cGMP) standards. The consultant will also maintain product recall and quarantine systems, prepare quality metrics, and collaborate with international stakeholders such as WHO and UNICEF. This role is integral to UNFPA's capacity-strengthening initiatives, which involve training supply chain professionals in cGDP and sharing technical expertise. The consultant will report directly to the Quality Assurance Analyst within the Product Quality Assurance team in Pillar 3 of the Supply Chain Management Unit (SCMU).

Duties and Responsibilities:
The consultant will be responsible for applying a risk management strategy to quality complaints and responses to regulatory quality alerts, maintaining a quality complaints log, and generating compliance reports for suppliers against technical specifications to support vendor qualification programs. They will assist in analyzing and managing deviations related to transportation and storage conditions, track and manage the CAPA system, and document analyses of non-compliances thoroughly. The consultant will perform and support the maintenance and closure of documents such as reports, exceptions, deviations, and change controls. They will monitor, perform, and document sampling/testing and inspection of reproductive health medicine or medical device samples, ensuring compliance with cGDP, cGMP, and UNFPA procedures. Additionally, they will maintain a robust product recall system, track quality metrics, review terms of references for Product Quality Assurance services, and collaborate with various stakeholders to ensure effective quality assurance of reproductive health medicines. Participation in Product Quality Assurance Team meetings and minor financial activities such as budget management may also be required.

Required Qualifications:
Candidates must have a minimum of 6 years of related work experience in quality assurance, product development, or quality control of pharmaceuticals or sterile health products. Experience with regulatory authorities concerning medical devices or health products is also required. Proven analytical and technical knowledge of reproductive health products is a strong advantage, as is familiarity with reproductive health commodities and medical terminology. Experience in coordinating workshops and knowledge of international markets, including sources, certifications, and controls, is desirable. Work experience with the UN or an international organization, as well as experience supporting developing countries, is an asset. Excellent interpersonal, written, and oral communication skills, along with team management skills, are essential.

Educational Background:
Completion of secondary education is required, with a university degree in Pharmacy, Pharmaceutical Sciences, Material Science, Medical Laboratory Science/Technology, Nursing, Biomedical Sciences, Public Health, or a related field considered an asset. Completion of relevant training or professional certification in Quality Assurance of health products is also advantageous.

Experience:
Candidates should possess a minimum of 6 years of relevant work experience in quality assurance or product development, particularly in pharmaceuticals or sterile health products. Experience with regulatory authorities regarding medical devices or health products is also necessary. Familiarity with reproductive health products and the ability to analyze and manage quality-related issues are critical for this role.

Languages:
Fluency in English is required, and working knowledge of another official UN language is considered an asset. Proficiency in additional languages can enhance communication with diverse stakeholders and is beneficial for collaboration in international settings.

Additional Notes:
The position is likely to be full-time, and while specific contract duration details are not provided, candidates should be prepared for a role that may involve international collaboration and engagement with various stakeholders. UNFPA promotes a work environment that values gender equality, diversity, and integrity, encouraging applications from underrepresented groups. Reasonable accommodations may be provided for applicants with disabilities to support their participation in the recruitment process. UNFPA does not charge any fees during the application or recruitment process.