E-DRUG: MSF is hiring: "QA pharmacist within the int. pharma coordination"
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Dear e-druggers,
MSF is hiring: QA pharmacist within the Int. Pharma coordination. The main
objectives of this position are:
- to coordinate the product assessment activities
- to consolidate the MSF QA documentation system: planning,
writing and revision of QA documents
- to provide technical guidance and support in quality related
topics: manufacturer GMP audits prioritization planning, handling of
complaints, further development of the UniQuality database, etc.
- to be the referent pharmacist for contact with specific working
groups
- to support NMSF European Supply Centers in a coordinated
approach towards access to quality medicines.
If you fit within the profile sought and are interested, do not hesitate to apply!
Kind regards,
Isabel
Full details
MEDECINS SANS FRONTIERES INTERNATIONAL
Quality Assurance pharmacist (QA)
Pharmacist position in MSF International Pharmaceutical Coordination
Location: Barcelona, Geneva, Paris, Brussels, Amsterdam
Contract: 80% position
Assignment: 1 year with possible extension after successful evaluation
Starting date: July 2019
Deadline for applications: 9th June 2019
I. MSF INTERNATIONAL*
Medecins Sans Frontieres (MSF) is an international, independent, medical
humanitarian organisation that delivers emergency aid to people affected by
armed conflict, epidemics, healthcare exclusion and natural disasters. MSF
offers assistance to people based only on need and irrespective of race,
religion, gender or political affiliation.
MSF International is the legal entity that binds MSF's 21 sections, 24
associations and other offices together. Based in Geneva, the MSF
International Office provides coordination, information and support to the
MSF Movement, as well as implements international projects and initiatives
as requested. The International Office also provides administrative support
to the MSF Access Campaign.
II. POSITION BACKGROUND
One of the objectives of the pharma network is to assure the quality of
medicines in MSF projects. The pharma network is mainly composed of
pharmacists working in the medical departments of the operational centers
(section pharmacists, pharmacy advisors), pharmacists in European Supply
Centres (ESC), pharmacists in the Access Campaign and regional/intersectional pharmacists.
Coordination of this network is done by the International Pharmacist
Coordinator (IPC) who has a permanent position within the International
Office.
Main activities of the International Pharmaceutical Coordination team (from
an International QA perspective) are:
- To maintain the coherence of the network (organization, meetings,
proactive follow-up and support)
- To coordinate the implementation of the MSF Qualification Scheme for
international procurement and all related activities with the support of
external experts
- To facilitate and ensure that common specifications and procedures are
implemented and used in all sections and ESCs
Quality Assurance pharmacist (QA)
Pharmacist position in MSF International Pharmaceutical Coordination
- To participate to external networks/meetings with other key international
actors (UNICEF, WHO, ICRC…) sharing the objectives to improve quality of
medicines on the international market.
Experience has shown that a dedicated person to quality assurance can
increase the impact of this work substantially. This position aims to take
the lead in the search of potential new sources for supply, in the final
product evaluations and in the consolidation of MSF QA system as well as
guiding a coordinated approach within the ESCs towards access to quality
medicines.
III. PLACE IN THE ORGANISATION
The QA pharmacist position is under the direct responsibility of the
International Pharmacist Coordinator (IPC).
S/he will be in close contact with the pharma network and particularly the
IMES (International Medicines Evaluation Session) group involved in product
evaluations, the Priority List group, the members of specific working
groups, the ITC (International Technical Coordination), etc.
IV. OBJECTIVES OF THE POSITION
The objectives of this position are to support the coordinator in the
following:
- To work on all pharmaceutical aspects linked to the search of sources,
selection and use of essential medicines identified as priority, including
support to ITC for any inclusion to MSF catalogues.
- To be the technical referent and to coordinate the product assessment
activities delegated to the IPC team by the OCs: final review and approval
of product dossiers (including their variations and monitoring), approval
of DOEs and organisation of IMES meetings.
- To consolidate the MSF QA documentation system: planning, writing and
revision of QA documents.
- To provide technical guidance and support in quality related topics:
manufacturer GMP audits prioritization planning, handling of complaints,
further development of the UniQuality database, etc.
- To be the referent pharmacist for contact with specific working groups
(malaria contact group and others like nutrition, etc. and guidelines team,
etc.).
- To support the ESCs in a coordinated approach towards access to quality
medicines, convening different stakeholders within supply, i.e. pharmacists
and purchasers as needed in order to support joint strategies to overcome
barriers.
V. MAIN RESPONSIBILITIES
Search, selection and use of priority essential medicines
- Support the IPC and ESCs in identifying potential new sources for the
list of priority medicines and in the organization and follow-up of the
priority list meetings.
- Support the ITC and working groups by conducting the QA/supply check
related to new medicines requests.
Management of MSF QA documentation system
- Be responsible for planning QA documentation revisions and new documents
to be created, drafting QA documents, making sure documents are correctly
stored in the share-point and master list is updated, and communicating
changes with the relevant pharmacists (IMES, IPC, pharma network).
- Organize the section pharmacists' annual product dossier audit on the
implementation of MSF Qualification Scheme carried out together with the
ESCs.
- Following audits of MSF QA system, is responsible for CAPA and
implementation of the recommendations linked to his/her scope of
competences.
- Write an annual report of the QA activities (products approved/not
approved/exceptionally approved/products monitored and variations assessed,
etc.)
Technical QA referent and coordination of product qualification activities
that are delegated to the IPC team by the OCs
- Briefing and coaching of newcomers (section pharmacists, intersectional
pharmacists, Access Campaign pharmacists or ESC pharmacists) on MSF QA
system, Qualification Scheme and product dossier assessments.
- Ensure close contact with the IMES pharmacists and be their focal point
person within the coordination for any support related to QA and
procurement.
- Coordinate product qualification activities within the IPC team: organize
IMES meetings, write minutes of the meetings and follow-up of the action
points, assign and monitor dossier assessment progress, perform final
review and responsible for approval of product dossiers (including
variations & monitoring) and DOEs.
- Be the focal point of external expert for the assessment of therapeutic
equivalence.
- Prepare documentation to submit to DirMed platform to inform decision on
exceptional validations, route M, of dossiers.
- Perform the annual risk analysis for prioritization of audits, TVs and
MVs planning and support the coordinator in the elaboration of the plan.
- Participate to manufacturing site audits and perform technical/monitoring
visits as per plan. Additional ad hoc support may be provided in other
specific TVs for LP.
Support to working groups, including malaria contact group
- Revise regularly with the working groups (malaria contact group or
others) the list of priority medicines, for which quality sources need to
be identified for MSF.
- Support working groups with no dedicated pharmacist in any pharma related
issue.
- Be responsible for entering/updating the technical information on
anti-malaria medicines quality reviews in UniQuality.
- Be MSF's focal point, internally (SPs, ESCs, AC) and externally
(manufacturers, ext. actors), regarding anti-malarial medicines and liaise
as needed with the responsible counterpart(s) in the ESCs.
- Contribute and participate in the work of the malaria contact group,
including: keep an overview on latest developments in treatments,
international recommendations and initiatives; monitor availability and
potential procurement problems.
Actively engage with the international pharmaceutical coordination team on
quality related topics:
- Contribute to the pharma strategy definition for the Pharma Network.
- Contribute to the planning and implementation of the network objectives
in line with the Pharma Network Plan of Action.
- Guide a coordinated approach within the ESCs towards access to quality
medicines.
- Facilitate the handling of quality complaints (international and local
purchase), their investigation and conclusion, and their good record
keeping.
- Provide technical inputs in further developments of the UniQuality tool.
- Liaise with responsible WatSan to ensure updated information on waste
management is available for all medicines, by providing technical input on
the nature of each molecule.
- Give support to the coordinator on specific requests or dossiers on
ad-hoc basis.
VI. PROFILE REQUIREMENTS*
Training: Senior pharmacist (with degree/diploma in pharmacy), preferably specialised in industry.
Experience: Minimum 5 years of experience. At least 2 years in MSF, experience with similar organisations may be considered. Experience in quality assurance is mandatory. Good knowledge of MSF quality and procurement policies.
Additional requirements: Fluency in English mandatory (French would be an asset)
Mature with strong interpersonal and organisational skills; Organized, with attention to detail; Team player; Ability to work and report independently; Willingness to travel regularly in Europe; Able to represent MSF in relevant meetings
APPPLY HERE: https://msf.recruitee.com/o/quality-assurance-pharmacist-qa
Only shortlisted candidates will be contacted
MSF is committed to achieving workforce diversity in terms of gender,
nationality and culture. Individuals with disabilities are equally
encouraged to apply
Isabel Lucas - Manzano
International Pharmacist Coordinator MSF
International Office
isabel.lucasmanzano@msf.org