International Consultant on quality control and assurance

UNDP is a key partner to the Global Fund to fight AIDS, Tuberculosis and Malaria and works in a number of countries as a Principal Recipient. A decision by the Multisectoral Expert Council selected UNDP as the Principal Recipient for the first phase of the HIV Round 3 Rolling Continuation Channel grant. The Global Fund to fight Aids, Tuberculosis and Malaria provides funds for the provide support of grants for the implementation of the National Programmes on HIV/AIDS, Tuberculosis and Malaria in the Republic of Uzbekistan. In its role as Principal Recipient under the HIV Round 3 Rolling Continuation Channel, UNDP is responsible for the financial and programmatic management of the Global Fund grant as well as for the procurement of pharmaceuticals, health and non-health products. The overall goal of the grant is to Continue Scaling up the response to HIV in Uzbekistan, with particular focus on Most at Risk Populations. In present time Uzbekistan is scaling-up the delivery of antiretroviral (ARV) therapy to HIV-positive eligible patients. A critical component of the scaling up of antiretroviral therapy (ART) is to ensure that all essential commodities, particularly antiretroviral medicines, for the required effective treatment regimens are available in sufficient quantity, are of assured quality, and are used appropriately. Thus, UNDP/GF Project "Continuing scale up of the response to HIV in Uzbekistan, with particular focus on the most at risk population" is searching for qualified candidate for the position of technical assistance for a quality control laboratory and development of the quality assurance plan. Under the guidance and direct supervision of the project Manager, the International Consultant will be responsible for development of quality assurance plan.

Duties and Responsibilities

Major tasks are required to be accomplished by the International Expert: To assess the readiness of the laboratory for WHO-prequalification, to prepare a costed action plan and the budget for its further WHO pre-qualification. To assist the GF PMU in preparation of the Quality Assurance Plan: to develop the QA Plan as per the existing guidelines. To help the laboratory to operate according to the principles of WHO recommended standards (Good practices for pharmaceutical quality control laboratories, GPCL) and be ready for the WHO-prequalification If needed, to advise the laboratory how to operate according to the principles of WHO GPCL To assess the laboratory quality management system as described in the quality management system documents and identify gaps to be addressed to meet WHO standards To review laboratory standard operating procedures and, if necessary, to propose their revision If necessary, to assess the compliance of the laboratory to the written procedures in the quality management system documents and identify non-conformances in the implementation of the quality management system To propose possible corrective actions, if necessary To advise on how to comply with requirements for prequalification, including general rules for safe working in a laboratory To advise on practical ways to facilitate implementation of quality management system Perform the inventory audit and review the quality management system implemented in the laboratory and its standard operating procedures Recommend issues and strategies that help to improve the quality management system in the laboratory Advise on practical ways to facilitate implementation of quality management system Cooperate with the laboratory in preparation of a costed implementation plan of corrective actions, which includes also timelines for provision of a progress report by the laboratory Assess the readiness for the official inspection within WHO prequalification procedure Write the report on the technical assistance Timeframe and fees The following deliverables and indicative schedule are expected from the consultancy contract. Exact dates of beginning and completion stages as well as scope of works for each phase can be corrected by Project Manager based on reasonable justification by the consultant. The project reserves the right, if necessary, to amend the terms of reference of a consultant on a written agreement. The final schedule will be agreed upon in the beginning of consultancy assignment. All deliverables should be submitted to the project by the Consultants in Russian. Deliverables I. Report Summary: Activities carried out within the technical assistance Report from the inventory audit, including observations made with references to WHO GPCL requirements Costed implementation plan (activities, budget and timelines for each activity) of corrective actions agreed with the laboratory. Timelines for provision of a progress report by the laboratory Opinion on readiness of the laboratory for the official inspection within WHO-prequalification procedure. The laboratory will be in a better position in terms of compliance to the WHO GPCL requirements and better prepared for the official inspection within the WHO-prequalification procedure Knowledge and skills of the staff as concerns the introduction and maintenance of quality management system in the laboratory will be improved The laboratory management and staff will have an understanding of the concrete steps involved in the implementation of quality management system Readiness of the laboratory for the official inspection will be assessed II. The Quality Assurance plan for pharmaceutical products procured for the GF grant (including the Annexes - the Action Plan, objectives, time table, etc.) Due date: December 22 This is a lump sum contract that should include costs of consultancy and other related costs, if any, required to produce the above deliverables. Payment will be released in 1 installment upon timely submission of respective deliverables and their acceptance by the Project Manager and UNDP CO.

Competencies

Excellent communications and result-oriented skills Ability to work in a team, ethics and honesty Ability to meet tight deadlines and to work effectively under pressure.

Required Skills and Experience

Education: University education in chemistry or pharmacy Experience: A minimum of 10-year laboratory experience, preferably in a national medicines quality control laboratory which has been WHO prequalified or ISO/IEC 17025 accredited or passed successfully an audit within the network of national medicines quality control laboratories Experience in introduction and maintenance of quality management system in the laboratory, preferably a national quality control laboratory Experience in audits/inspections of quality control laboratories Language Requirements: Knowledge of Russian is a must and English is an asset DOCUMENTS TO BE INCLUDED WHEN SUBMITTING THE PROPOSALS Proposal: Explaining why they are the most suitable for the work Applicants are required to fill and sign a UNDP Personal History Form and submit it on the online application. The P11 Form can be obtained at http://www.undp.uz/en/download/index.php?type=file&parent=3209&doc=100739 Application process: To submit your application online, please follow the steps below: Download and complete the UNDP Personal History Form (P11). Merge your P11 and Proposal into a single file. Click on the Job Title. Click “Apply Now” button, fill in necessary information on the first page, and click “Submit Application”. Upload your P11 form instead of CV. You will receive an automatic response to your email confirming receipt of your application by the system. Only shortlisted candidates will be asked to provide a financial proposal FINANCIAL PROPOSAL This is a lump sum contract. The financial proposal shall specify a total lump sum amount. In order to assist the requesting unit in the comparison of financial proposals, the financial proposal will include a breakdown of this lump sum amount (including travel, per diems, and number of anticipated working days). The payment will be made in one installment to be issued upon completion and submission of certification of payment for each installment as well as the Performance Evaluation Form (PEF) on the works performed as indicated in the terms of reference for the final payment. Travel: All envisaged travel costs must be included in the financial proposal. This includes all travel to join duty station/repatriation travel. In general, UNDP does not accept travel costs exceeding those of an economy class ticket. Should the IC wish to travel on a higher class he/she should do so using their own resources. In the case of unforeseeable travel, payment of travel costs including tickets, lodging and terminal expenses should be agreed upon, between the respective business unit and Individual Consultant, prior to travel and will be reimbursed. EVALUATION The individual consultants will be evaluated based on the Cumulative analysis methodology. The award of the contract will be made to the individual consultant whose offer has been evaluated and determined as: a) responsive/compliant/acceptable b) Having received the highest score out of the set of weighted technical and financial criteria specific to the solicitation. * Technical Criteria weight – 70%; Background and education 30%; Years of relevant experience 30%; Language skills 10% * Financial Criteria weight – 30% Only candidates obtaining a minimum of 49 points for the Technical Criteria will be considered for the Financial Evaluation

UNDP is committed to achieving workforce diversity in terms of gender, nationality and culture. Individuals from minority groups, indigenous groups and persons with disabilities are equally encouraged to apply. All applications will be treated with the strictest confidence.

International Consultant on quality control and assurance