Myanmar: Consultant for Wholesaler MQAS Audit - GFATM Program

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JOB TITLE: Consultant for Wholesaler MQAS Audit - GFATM Program

Introduction:

Save the Children has been the coPrincipal Recipient (PR) of three grants under the Global Fund to fight AIDS, TB and Malaria in Myanmar since January 2011. Under the first Phase of the Round 9 grants (2011 2012), Save the Children and its implementing partners, known as subrecipients (SRs), delivered HIV, malaria and Tuberculosis (TB) services at the health facility and community levels across 232 townships (out of 330) in all 17 states and regions in Myanmar. After successful implementation, Save the Children, under the leadership of the Myanmar Health Sector Coordinating Committee (MHSCC) and the National Programs, signed three additional Global Fund Grants under the New Funding Model (NFM) for 20132016 and has received a cost extension for the 2017 implementation period. Under these grants, Save the Children disburses Global Fund financing to 18 SRs in total (6 for TB, 7 for Malaria and 16 for HIV) covering all 17 states and regions of Myanmar.

A team of 40 professionals are employed to work exclusively in the management of the GFATM grants to ensure that activities are technically sound and are implemented following the adequate quality standards. This includes providing support on financial and program management to SRs, procuring pharmaceutical and health products, and reporting on program performance to Global Fund and the MHSCC. Save the Children participates in the national level multistakeholder board, MHSCC, as well as the Malaria, TB and HIV and AIDS Technical Strategy Groups to ensure sound technical implementation and effective coordination of programs for these three diseases.

For the 2017-2020 implementation period, SCI as launch an expression of interest to invite large Procurement Agents (including wholesaler) to be pre-qualified for the supply of health and pharmaceutical products under Global Fund Grant in Myanmar. Also, SCI Myanmar is seeking now to hire an expert to support GPT at London to do a "site quality assessment" of one of the pre-selected supplier.

Purpose of Consultancy:

SC-PR seeks support to conduct a "quality site assessment" of a pharmaceutical and health products wholesaler that has been pre-selected during an EOI process. The consultant will lead on a SCI GPT assessment (Assessment methodology based on WHO MQAS and WHO GDP standard). The GPT will be present on the assessment.

The consultant is expected to carry out the following key tasks:

1 To conduct and lead a quality on-site assessment of a health and pharmaceutical wholesaler located in Austria. The auditor is expected to use the SCI audit tool, following the principles of WHO MQAS and WHO GDP. The auditor is expected to review quality documentation in advance and develop an audit plan and focus areas for an audit. This must be communicated to the GPT and agreed in advance of the audit. 2 To prepare and submit, within thirty (30) calendar days of the inspection, a final WHO MQAS and GDP inspection report of the supplier:

Report must outline all activities conducted and all observations, including adherence to the WHO MQAS and WHO GDP standard and good practice. It must also include deviations and non-conformities to the WHO MQAS/GDP standard. The report must clearly define and categorise the observed deficiencies and recommendations on corrective/preventative actions required for each, to facilitate corrective actions and preventive actions (CAPA) by the wholesaler.

1 To ensure that any non-conformities/ deviations from the WHO MQAS/ GDP standard have been addressed with CAPA by each manufacturer before issuing the final report. This must be done by checking for evidence of implementation for each within 15 calendar days of the report being sent to the wholesaler. 2 To provide SCI with procurement recommendations in terms of WHO MQAS/WHO GDP compliance on purchasing based on the inspections and the follow up.

Person Specifications:

Qualifications

Essential:

• Advanced degree in pharmacy or Advanced degree in chemistry

Experience

Essential:

• Experience (> 10 years) in management of health and pharmaceutical supply with relevant/recent expertise (less than 2 years) on auditing/pre-qualification of manufacturer and/or wholesaler (GMP/GDP experience (past or present) in Stringent National Medicines Authorities or in international organization such as WHO prequalification program; or practical experience as auditor, according to international standards (EU/US FDA/WHO) and preferably in developing countries)

Competencies

Essential:

• Familiarity with WHO MQAS and WHO GDP and best practice guidance on supply chain (Good manufacturing practise, Good Storage practices and Good distribution practises).
• Fluent speaking/written English and German is required (most of document to be reviewed are in German language and report will be required in English)

GUIDANCE FOR APPLICANTS

1 How to best develop your application

Please ensure your expertise for this position is contained in a concise cover letter and accompanied by your CV(s). In your letter please explain clearly the skills, experiences and characteristics that make you especially suited to fulfil the statement of work and terms of reference. The structure and content of your letter will be an important part of the pre-selection process.

Important: Please include in your proposal an inclusive daily consultancy fee in US $ (excluding travel, accommodations, hotel expense, visa) for performing the required services.

All documents must be submitted in English. The application number and your individual/company name must be clearly indicated in the subject line of your e-mail and your proposal letter.

Application which are incomplete or non-responsive may not be considered in the review process.

SCI-PR reserves the right to contact any persons listed in your proposal or CV in order to gain a better understanding of your past performance and experience.

1 General Instructions

• SCI-PR may (a) reject any or all application.
• SCI-PR will be under no obligation to reveal, or discuss with any applicants, how a cover letter and CV were assessed, or to provide any other information relative to the selection process. Consultants whose application are not selected, shall have not have any claim whatsoever for any kind of compensation, cost or liability against SCI-PR.
• This application shall not be construed as a contract or a commitment of any kind. This request for application in no way obligates SCI-PR to award a contract, nor does it commit SCI-PR to pay any cost incurred in the preparation of the application. Applicants are solely responsible for their own expenses, if any, in preparing and submitting application. This would include any costs incurred during subsequent meetings and negotiations if applicant is pre-selected for further interview.
• In addition to the written CV and cover letter, SCI-PR may request applicants to make oral presentations in English or to participate in a meeting, video conference or telephone call. The date, time, and place for such (if any) will be communicated to relevant applicants. Information obtained through oral presentations will be considered in the overall evaluation process.
• Any questions concerning this position must be submitted in writing via email to SCI staff member below. Also we encourage consultant to inform SCI team member below as soon as they wish to apply in order to allow the team to share with you additional information regarding this application (if any happen during this process).

Application Email: Please apply with a covering letter and up-to-date CV to: 'dkoh.35098.3830@savethechildrenint.aplitrak.com'