E-DRUG: Opportunity: Quality Assurance Consultant - Myanmar
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Terms of Reference for Quality Assurance Consultant
Title: Quality Assurance Consultant
Client/Country: Myanmar
Duration: 3 months
Expertise: Pharmaceutical science and quality management
Enquiries close:
31 October 2011
Enquiries to:
Charmaine Turton
WHO Network for HIV and Health in the Western Pacific Region
charmaine.turton@sesiahs.health.nsw.gov.au
1. Background
. UNOPS Myanmar has been appointed as Principal Recipient to the Global Fund Round 9 Grant. In implementation of the Global Fund Grants, UNOPS as PR to GF will carry out the procurement and supply chain management of various pharmaceuticals and other health products strictly following the GF requirement on quality assurance.
. The GF grant funds may only be used to procure antiretroviral, anti-tuberculosis and anti-malaria finished pharmaceutical products (FPPs) that meet the established following standards.
. In order to comply with the GF requirement on Quality Assurance/ Quality Control (QA/QC) of health products, a QA/QC expert is needed in PR-UNOPS Office for a maximum period of 3 months, full time, to strengthen the capacity of the Procurement and Logistic Unit for providing the high level services to the grant implementation.
2. Purpose and Objectives
. The overall purpose is to ensure that Procurement and Supply Chain Activities of the PR GF in delivering health products of HIV/AIDS, TB and Malaria to the affected patients are in full compliance with the Global Fund Quality Assurance Policy for Pharmaceutical Products.
. The specific objectives of the assignment are: (i) Build capacity of the relevant staff of PR GF and SRs in Quality Assurance Policy and Processes (ii) Develop Manuals and SOPs for Quality Assurance.
3. Scope and Tasks
Under the direct supervision of the Procurement Specialist and overall supervision of the Programme Coordinator of PR-UNOPS, the Quality Assurance Consultant is responsible for the following tasks:
. Capacity building of the UNOPS Myanmar procurement and logistics unit and Sub-Recipients on QA/QC of health products over the entire supply chain.
. Review and finalization of the Quality manual as regards to health products based on WHO's model quality assurances system for procurement agencies and interagency guidelines of operational principles for pharmaceutical procurement.
. Develop TORs for inspecting agencies and testing Laboratories.
. Preparation of SOPs for some of the following -
i. Selection of Product
ii. Technical evaluation of bids
iii. identifying and reporting counterfeit products;
iv. reporting of deviations;
v. appointing evaluators of product information;
vi. sending out, receiving and evaluating supplier questionnaires;
vii. handling recalls;
viii. policy for regular re-inspection;
ix. routine follow-up of inspections;
x. inspection fault correction; and
xi. Standard formats for inspection reporting.
xii. Pre-shipment Product testing
xiii. Sampling of products from the field for QC testing.
xiv. Any other SOP as deemed required.
4. Deliverables/Outputs
. Capacity building of the UNOPS Myanmar procurement and logistics unit and Sub-Recipients on QA/QC of health products over the entire supply chain.
. Quality manual as regards to health products based on WHO's model quality assurances system for procurement agencies and interagency guidelines of operational principles for pharmaceutical procurement.
. TORs for inspecting agencies and testing Laboratories.
. SOPs for some of the following: Selection of Product; Technical evaluation of bids; reporting of deviations; etc.
5. Outcomes
. Relevant staff of UNOPS Myanmar procurement and logistics unit and Sub-Recipients conversant in QA/QC.
. All essential manuals, TORs, SOPs and other documents on QA/QC developed.
6. Inputs
. The Quality Assurance Consultant will be working with the PR GFATM Procurement and Logistics Unit under the overall supervision of Programme Coordinator. This consultancy will be funded by UNAIDS, with day-to-day management by PR-UNOPS.
7. Selection criteria
. Master's Degree in Pharmaceutical Science. Preference will be given to those who are holding an additional qualification in Quality Management. Minimum 10 years in the field of QA/QC for Pharmaceuticals and other health products. Sufficient experience in working with the GF on QA/QC related matters is highly desirable.
8. Timing/Scheduling
. The assignment of a Quality Assignment is for a maximum period of 3 months, full time.
9. Reporting
. The Quality Assurance Consultant will directly report to the Procurement Specialist and Programme Coordinator of PR-GFATM.
Charmaine Turton
WHO Network for HIV and Health in the Western Pacific Region
charmaine.turton@sesiahs.health.nsw.gov.au