E-DRUG: World Bank Seek Highly Qualified Senior GMP Inspector (Consultant) for Market Survey
-------------------------------------------------------------------------------------------------------------------
Background
Strengthening pharmaceutical management can contain costs and maximize efficiencies. Effective procurement and distribution, a robust quality assurance system, and financial and managerial audits decrease waste.
While financing for, and access to, medicines is improving overall, the quality of medicines being consumed remains worrisome. Dramatic cases such as diethylene glycol poisoning deaths of children have been reported (Cockburn, 2005). Available studies published in scientific journals and project reports have documented product quality problems in as many as 20 Sub-Saharan countries (World Bank, 2012). Most recently, experts have claimed that some drug manufacturers cut corners and make substandard drugs for markets with under-developed or emerging regulatory oversight.
Good Manufacturing Practice (GMP) is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products.
The majority of national regulatory authorities are obliged by law to have systems in place to verify the GMP status of medicinal product manufacturers whose products are marketed in their territory. Most "mature" regulatory authorities ensure that these manufacturers in their territory are subject to robust routine GMP inspections.
Consultant Roles and Responsibilities
The World Bank is seeking a highly qualified Senior GMP Inspector to conduct GMP inspections for a market survey in one or more select low-income countries. The Senior GMP Inspector will support the building of evidence on the state of the pharmaceutical market.
The selected candidate will:
* Support the design, planning, roll-out, and implementation of a study on the state of the pharmaceutical market and medicines manufacturing in one or more selected low-income countries;
* Conduct "light" GMP Inspections (sampling methodology to be defined) for the purpose of gathering study data;
* Provide high level policy advice, including offering international comparative perspectives and recommending policy options and implementation strategies;
* Contribute to the creation and sharing of knowledge by summarizing and documenting results and lessons learned in the planning and implementation of the study
Qualifications
The Senior GMP Inspector should:
(a) be academically qualified in a recognized scientific/technological discipline related to pharmaceuticals (normally pharmacy, chemistry or microbiology); direct personal experience of pharmaceutical manufacture or control is an advantage;
(b) have satisfactorily completed a recognized training course on auditing quality management systems;
(c) have undergone at least 10 days of training per year (e.g. courses, symposia, conferences, etc.);
(d) have a competent working knowledge of the WHO guidelines on GMP for pharmaceutical products and/or the GMP inspection procedures of a "stringent"/mature national regulatory authority;
(e) have undergone conducted GMP inspections alone;
(f) have the necessary personal qualities of integrity, tact and character to perform the duties of a GMP inspector.
If interested and available for a total period of 30 (non-consecutive) days starting as soon as possible, please email your CV (including references) and a short cover note to:
lkasonde@worldbank.org
Many thanks,
Lombe
Lombe Kasonde
Health, Nutrition and Population Global Practice
The World Bank
lkasonde@worldbank.org