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Quality Assurance Manager Job in Nairobi Kenya

USAID | Kenya Pharma is a USAID funded project managed by Chemonics International that seeks to establish and operate a reliable, sustainable pharmaceutical supply chain management system. 

Its aim is to forecast, procure, store, and distribute drugs, supplies, and equipment needed for the care and treatment of persons with HIV/AIDS in Kenya. 

Kenya Pharma has the following vacancy.
Position Title: Quality Assurance Manager
Reports to: Director of Technical Coordination
Location: Nairobi
Position Description
The Quality Assurance Manager oversees all aspects of the quality assurance component of the project. Working with subcontractors and suppliers, s/he ensures the quality and suitability of pharmaceuticals and commodities procured for the project.

S/he ensures the quality and safety of delivered products through independent testing and ensures that project staff and all subcontractors follow proper pharmaceutical handling procedures to guarantee that product quality is maintained. 

S/he will also keep up to date on HIV/AIDS-related pharmaceutical information and ensure that the project makes procurement decisions based on the latest information about drug safety and availability.

Specific Duties:
1. Subcontract management: Liaise with, and oversee, subcontractors on inspection, sampling and chemical analysis of procured commodities prior to shipment.
2. Procurement: Manage technical aspects of the procurement component; update RFPs with technical specifications and requirements of products to be procured; update procurement manual with the quality assurance requirements; advise the bid and evaluation committee on products’ and manufacturers’ documentation relating to Pharmacy and Poison’s Board registration and USFDA approval; undertake supplier prequalification and selection.
3. Inspection, sampling and analysis: Work closely with the warehouse team to undertake inspection and sampling of commodities in the warehouse prior to distribution. Carry out regular random sampling and quality checks on products supplied; analyze reasons for poor quality, with the aim of minimizing the incidence of this problem; liaise with local and international WHO prequalified labs in undertaking laboratory analysis of products procured by Kenya Pharma.
4. Management of medical waste: Work with the necessary national regulatory authorities (NEMA and PPB) to ensure safe disposal of medical waste i.e. expired, damaged or obsolete commodities.
5. Drug quality concerns: Investigate and respond to customer concerns relating to drug quality; develop a database of reported cases of adverse drug reactions, labeling changes, safety alerts and recalls; oversee the drug recall process; carry out post-distribution surveillance to identify and respond to customers’ complaints and needs.
6. Drug manufacturer and supplier audits: Carry out manufacturer/supplier audits to ensure compliance with Good Manufacturing Practices and Good Distribution Practices.
7. Documentation, Storage and handling: Develop data collection tool templates for QA, storage and handling; oversee the development, implementation and review of standard operating procedures, systems and work instructions on QA, storage and handling, compliant with Government of Kenya laws and regulations, ISO 9001:2008 principles, Chemonics International procedures and USAID rules and regulations
Minimum Qualifications
  • Formal education and license in pharmacy at the masters level (or higher);
  • At least 5 years’ demonstrated experience in pharmaceutical management;
  • Demonstrated knowledge of pharmaceuticals and commodities for HIV/AIDS, particularly Anti-Retroviral Therapy (ART) regimens;
  • Demonstrated knowledge of Quality Assurance procedures and QA program implementation, particularly laboratory operations analysis and process improvement;
  • Ability to effectively communicate both orally and in writing;
  • Demonstrated ability to administer effective working relationships with senior Government personnel, health workers, procurement officials, U.S. and foreign government organizations, and the private sector;
  • English fluency.
Send your CV and cover letter with three professional referees to not later than 22 July, 2012.

Please include position title in the subject line of the email.

For a more comprehensive scope of work for this position, visit

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