UNICEF Supply Division LTA Roster of Consultants: Medicine Dossier Assessors and GMP/GSDP Auditors, Copenhagen, 3 years, Remote

Organizational Context

UNICEF works in over 190 countries and territories to save children’s lives, defend their rights, and help them fulfill their potential. Committed and passionate, UNICEF promotes the rights of every child, viewing it as a calling. We offer diverse opportunities for professional and personal development, reinforcing a sense of purpose while serving children and communities globally.

Job Purpose

UNICEF Supply Division aims to establish a roster of pre-qualified external consultants to enhance its capacity for technical assessment of medicinal product dossiers and audits against Good Manufacturing Practices (GMP) and Good Storage and Distribution Practices (GSDP). This roster will also provide experts to support the increasing demand related to UNICEF's localization agenda for medicinal products and expanded supply operations in low- and middle-income countries. Quality assurance (QA) is fundamental to UNICEF’s mandate, ensuring timely access to safe, efficacious, and quality-assured medicines. Robust QA processes, including rigorous technical assessment, GMP audits, GSDP assessments, and quality control, are crucial for managing risk, ensuring regulatory compliance, and safeguarding beneficiaries across global and local supply chains. The objective is to create a pool of dossier assessors and GMP/GSDP auditors with proven regulatory experience and strong reporting discipline, thereby strengthening country and regional procurement while maintaining global quality assurance standards.

Responsibilities

Consultants on this roster will primarily undertake two key functions to support UNICEF's quality assurance mandate, ensuring the safety and efficacy of medicinal products. For Medicine Dossier Assessors, responsibilities include conducting comprehensive technical assessments of medicinal product applications. This involves a meticulous evaluation of administrative documentation, a thorough assessment of the quality of Active Pharmaceutical Ingredients (API) and Finished Pharmaceutical Products (FPP), and a critical review of safety and efficacy data. Assessors are also expected to provide related capacity-building support when requested, contributing to the strengthening of local expertise. For GMP/GSDP Auditors, the role entails performing rigorous Good Manufacturing Practices (GMP) audits of various manufacturing sites. This includes facilities producing finished medicinal and nutritional products, as well as sterile API powder for injection (ready to fill) manufacturing sites. Furthermore, auditors will conduct detailed Good Storage and Distribution Practices (GSDP) assessments, covering warehousing, packaging, distribution facilities, and freight forwarders. These roles are critical for ensuring stringent regulatory compliance, effectively managing supply chain risks, and consistently upholding global quality assurance norms and standards to safeguard beneficiaries across all UNICEF operations.

Work Experience

Candidates must possess proven regulatory experience relevant to the technical assessment of medicinal product dossiers and/or auditing against Good Manufacturing Practices (GMP) and Good Storage and Distribution Practices (GSDP). This experience is crucial for ensuring robust quality assurance processes and regulatory compliance within global and local supply chains.

Skills

Regulatory experience, Strong reporting discipline, Technical assessment of medicinal product dossiers, GMP auditing, GSDP auditing, Quality control, Risk management, Regulatory compliance, Capacity-building

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