E-DRUG: Short term consultant for QA assessment of supplier - deadline Feb 10
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Dear all,
We would like to hire a short term consultant to conduct a quality
assessment of a Wholesaler (Austria) in March.
Can you please share this vacancy.
Thanks you for your support.
Lionel
Save The Children *
vacancy announcement
JOB PROFILE
JOB TITLE: Consultant for Wholesaler MQAS Audit GFATM Program
ASSIGNMENT No.: PR-17/005/SCI-GF/RFP*
Issue Date: 3rd February 2017
TEAM/PROGRAMME: Save the Children-Myanmar, Global Fund Principle
Recipient
LOCATION: Austria
Number of Position: Consultant
type of Contract: Agreement
CHILD SAFEGUARDING:
Level 1: the role holder will not have contact with children and/or young
people, or access to personal data about children or young people, as part
of their work; therefore a police check will not be mandatory unless the
content or location of the role changes, in which case the Child
Safeguarding level will be reviewed.
Closing date/time Friday 10th February 2017 15h00 (Myanmar Standard
Time)
Consultancy Role: SC-PR seeks technical support to assist SCI London
Global Pharmacy Team (GPT) in doing MQAS Audit of one of her pre-selected
medical supplier in Austria.
Introduction:
Save the Children has been the 'Principal 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 sub-recipients
(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 2013-2016 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 multi-stakeholder 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 suppliers.
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 categorize the observed
deficiencies and recommendations on corrective/preventative actions
required for each, to facilitate corrective actions and preventive actions
(CAPA) by the wholesaler.
3. 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.
4. To provide SCI with procurement recommendations in terms of WHO
MQAS/WHO GDP compliance on purchasing based on the inspections and the
follow up.
1. Duration: From 1st March 2017 to 30th March 2017 (*estimated work
time during this period - 8 working days as follow / not including
transport)
· 2 days review of documents preparation of the consultancy in
collaboration with SC-GPT
· 3 days assessment
· 3 days completion of reports
2. Facilities to be provided by Save the Children
· All accommodations to go to the site and on site will be
cover/reimbursed by SCI upon presentation of invoices (i.e.: hotel, taxi to
airport, visa¦ as required).
· Travel and accommodation must be booked through the SCI travel
desk.
3. Payment Breakdown
· Plane ticket to be taken by SCI and provided to consultant after
signature of the consultancy contract
· Consultancy charges to be reimbursed by SCI after submission of
final report within forty five (45) day following reception of invoice.
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 practice, Good Storage practices and
Good distribution practices*).
· 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)
SCI values are indicated below and we expect all candidates to align with
such values.
Accountability:
· Holds self-accountable for making decisions, managing resources
efficiently, achieving results together with children and role modelling
Save the Children values
· Holds the team and partners accountable to deliver on their
responsibilities - giving them the freedom to deliver in the best way they
see fit, providing the necessary development to improve performance and
applying appropriate consequences when results are not achieved
· Creates a managerial environment in-country to lead, enable and
maintain our culture of child safeguarding
Ambition:
· Sets ambitious and challenging goals for self and team, takes
responsibility for own personal development and encourages team to do the
same
· Widely shares personal vision for Save the Children, engages and
motivates others
· Future oriented, thinks strategically and on a global scale
Collaboration:
· Builds and maintains effective relationships, with own team,
colleagues, members, donors and partners
· Values diversity, sees it as a source of competitive strength
· Approachable, good listener, easy to talk to
Creativity:
· Develops and encourages new and innovative solutions
· Willing to take disciplined risks
Integrity:
· Honest, encourages openness and transparency
· Always acts in the best interests of children
Submission : Please submit by email your CV and cover letter in accordance
with the below instructions no later than closing date and time mentioned
above to:
Procurement1.Myanmar@savethechildren.org
Consultants are well advised not to send their questions to the email
address reserved for receipt of EOI. These e-mails are not monitored on
regular basis and thus no responses will be provided to the questions
submitted to the above address.
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.
Applications 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.
2. 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*).
*khaingsapal.htway@savethechildren.org*
c/c: Lionel Duinat, Senior PSM Manager, lionel.duinat@savethechildren.org
Not later than 5 P.M., 7th February 2017 (Tuesday). *