Overview
UNICEF Supply Division seeks to establish a roster of pre-qualified external consultants to assess medicinal product dossiers and conduct GMP/GSDP audits. The roster will augment in-house capacity and support the localization agenda for medicinal products.
Key Responsibilities
- Conduct technical assessments of medicinal product applications, including administrative, quality, and safety/efficacy data.
- Provide written assessment reports with clear queries, conclusions, and recommendations.
- Plan and conduct GMP audits of finished medicinal and nutritional product manufacturing sites.
- Plan and conduct GSDP audits for warehousing, packaging, distribution facilities, and freight forwarders.
- Prepare audit reports, classify observations, and follow up on CAPA.
- Contribute to capacity-building when required.
Required Experience
- Category A: At least 8 years’ progressive experience relevant to pharmaceutical regulation, including hands-on product assessment, at National level. Experience at regional and global level is an added advantage.
- Category B: At least 8 years’ proven regulatory inspection experience in GMP of both sterile and non-sterile medicinal finished product manufacturers and/or sterile API powder for injection (ready to fill) manufacturing sites as applicable, with audit or inspection training and strong documentation/reporting skills.
- Category B: At least 8 years’ proven regulatory audit experience in GSDP, with audit or inspection training and strong documentation/reporting skills.
- Category B: Experience with auditing of low-moisture and specialized food products required for relevant audits with audit or inspection training and strong documentation/reporting skills.
Qualifications
• Advanced university degree (Master’s or higher) in Pharmacy, Pharmaceutical Sciences/Regulation or related field with specialization in Chemistry, Manufacturing and Controls (CMC).
