Pharmaceutical GMP Consultant at U.S. Pharmacopeial Convention (USP)

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

Since its founding in 1820, USP has helped secure the quality of the American drug supply. Building on that legacy, USP today works with scientists, practitioners, and regulators of many nations to develop and revise standards that help protect public health worldwide.

The Promoting the Quality of Medicines (PQM) program, supported by the U.S. Agency for International Development (USAID) and implemented by the U.S. Pharmacopeial Convention CUSP), helps developing countries effectively address critical issues related to poor quality medicines. It helps USAID-assisted countries strengthen their quality assurance and quality control systems to better ensure the quality, safety, and efficacy of medicines that reach patients.

The U. S. Pharmacopeial Convention (USP) is seeking qualified candidates to fill the vacant position, which will be based in Lagos, Nigeria:

Position: Pharmaceutical GMP Consultant

Location: Lagos
Reports To: Chief of Party, USP PQM Nigeria

Summary of the Position

• The Consultant for Pharmaceutical GMP will support implementation of the USP PQM work plan activities in Nigeria, providing technical assistance in Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GIP), particularly in guiding local manufacturers of maternal and child health medicines (MCH) to participate in the World Health Organization (WHO) Pre-qualification 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 GMP standards and WHO requirements for the prequalification of medicines.
• The Consultant will provide high level guidance on all aspects of product development and Common Technical Document (CTD)-format 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 technical assistance 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 assistance 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

Experience

• 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
  

Application Closing Date
18th September, 2014

Method of Application
Interested applications must be sent via email to: [email protected]

Applicants should specify the position(s) for which they are applying on their application cover page or curriculum vitae (Resume)