Pharmaceutical GMP Consultant at US Pharmacopeial Convention (USP)

Reports to: Chief of Party, USP PQM Nigeria
Summary of the Position

• The Consultant for Pharmaceutical Gt-1P will support implementation of the USP PQt-1 work plan activities in Nigeria, providing technical assistance in Good Manufacturing Practices (GMP), Good Oinical Practices (GCP), and Good Laboratory Practices (GLP), particularly in guiding local manufacturers of maternal and child health medicines (MCH) to participate in the World Health Organization (WHO) Pre-quatification Programme.
• The Consultant will provide ongoing technical support to local manufacturers on achieving compliance with WHO requirements to submit finished pharmaceutical product dossiers for WHO Pre-qualification status.
• The Consultant must be familiar with both international current G"1P standards and WHO requirements for the pre-qualification of medicines.
• The Consultant will provide high level guidance on all aspects of product development and Common Technical Document (CTD)-forrnat dossier submission, including stability studies, dissolution profiling, and bioequivalence studies, as needed.
• The Consultant will work with local manufacturers and with local contract research organizations(CRO) to support the USP PQM technicalassistance program, financed under USAID.
• The Consultant will also support PQM activities related to The National Agency for Food and Drug Administration and Control (NAFDAC) GMP activities, including laboratory compliance and other regulatory functions.

Roles and Responsibilities

• Provides ongoing GMP technical assistance support to local manufacturers of MCH and other medicines under the USP PQM technical assistanoe program in Nigeria.
• Supports the Chief of Party and staff involved in USP PQM quality assurance and quality control activities in implementing MCH work plan activities.
• Provides technical support to pharmaceutical manufacturers on product development and requirements
• Provides technical assistance to support NAFDAC's laboratory WHO Pre-qualification activities
• Performs other duties as requested

Minimum Qualifications:
Education

• Bachelor's degree in chemistry, pharmacy, or related field; a higher degree will be an advantage.
• Relevant experience in GMP in the pharmaceutical industry or regulatory environments Some experience in the establishing compliance with quality systems within pharmaceutical manufacturing companies.
• Knowledge of and experience with the WHO Pre-qualification of Medicines Programme will be considered a plus
• Experience working within a GMP regulated Quality control laboratory is also a plus