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.
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 recruit@kenyapharma.org 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, visithttp://www.kenyapharma.org/about_us/careers
