Location: Geneva
Deadline: Tuesday, 08 October 2013
Description
Deadline: Tuesday, 08 October 2013
Description
TECHNICAL OFFICER (HQ/13/QSM/FT394)
17 September 2013
The mission of WHO is the attainment by all peoples of the highest possible level of health.
Vacancy Notice No:HQ/13/QSM/FT394
Title: Technical Officer
Grade: P5
Contract type: Fixed-Term Appointment
Duration of contract: 12 months
Date: 17 September 2013
Application Deadline: 8 October 2013
Duty Station: Geneva, Switzerland
Organization unit: HQ/QSM - Quality Assurance and Safety: Medicines (HQ/QSM), HQ/PQM Prequalification of Medicines Programme (HQ/PQM)
OBJECTIVES OF THE PROGRAMME :
The department of Essential Medicines and Health Products (EMP) works with Member states and partners to improve the access to essential medicines and other health technologies of assured quality for patients, and to promote that these are used rationally. The EMP department works with the HIS (Health Systems and Innovation) cluster departments in the wider framework of Universal Health Coverage and category 4 of the Global programme of Work, and cooperates with disease oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Millenium Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centers. The objective of the Prequalification of Medicines Programme (PQP) is to optimize HQ's technical advice and political support to member states by developing and promoting norms, standards and guidelines for quality, safety, rational use and efficacy of medicines; to perform inspections assessing compliance with WHO (and other related) norms and standards.
Description of duties:
The Expert Inspector is responsible for, in liaison with head of inspections, the development, delivery and maintenance of the prequalification programme quality management system, inspector induction, training and competency assessment programs and technical capacity building programmes for staff from manufacturers and national medicines regulatory authorities. This position also has responsibility for development of, and on-going monitoring of inspections complaints procedures and performance data and developing and implementing appropriate strategies for addressing identified issues with the aim of ensuring that necessary inspections and related technical support to manufacturers are performed professionally and consistent with WHO norms and standards. The PQP Expert Inspector will also contribute to the delivery of the PQP inspections program as required.
To support, in liaison with head of inspections, a rigorous inspection programme through building and maintaining quality and technical standards.
Specifically:
1. To take a lead, in liaison with head of inspections, in technical areas and oversee technically demanding areas/inspections and in particular to:
a. develop, mentor and train staff WHO inspectors;
b. assure consistency and clarity of technical advice and decision making by the Inspectorate;
c. audit all inspectors at least once per year for professional competence and inspectional technical skills.
2. To shape and influence the future PQP framework by providing timely input into policy and strategy development for future models for inspections.
3. To facilitate the development, and subsequently, represent and promote PQP inspections positions and inform and feedback to the Inspectorate on international issues such that representation and information transfer is effective working together with other senior prequalification programme staff, national and regional regulatory authorities and relevant international organisations such as The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Society for Pharmaceutical Engineering (ISPE).
4. To ensure operational quality by provision of effective operational interpretation of guidance for inspectors and stakeholders and take lead in the training and audit of staff and external inspectors.
5. To ensure new areas of guidance are appropriately implemented within the inspectorate.
6. To coordinate, in liaison with head of inspections, representation of PQP at an international level, mainly on GMP and other technical matters.
7. To assist in undertaking research of relevant prequalification programme information, preparing reports and presenting information, data and results, including training materials in the areas of work and competence.
8. To contribute to the relevant WHO normative activities linked to the Expert Committee on Specifications for Pharmaceutical Preparations and training workshops organized by Essential Medicines and Health Products (EMP) department according to the technical competence (GMP and quality assurance related issues).
9. To work, in liaison with head of inspections, with other inspectorates to increase inspectorate effectiveness and efficiency. This includes initiating a programme of pre-audit of potential applicants for prequalification to ensure that as far as possible any gaps in standards versus PQP requirements are identified for CAPA prior to formal submissions being made.
10. To lead and chair the appeal process for inspection findings in case of controversy.
REQUIRED QUALIFICATIONS
Education:
Essential: Master's level university degree in a relevant field of study such as pharmacy, chemistry or microbiology. Studies in pharmaceutical chemistry and/or pharmaceutical technology.
Desirable: Qualifications respective to quality assurance status within regional structures, i.e. Qualified Person within the EEA, or Responsible Person under PIC/S GMP with experience of releasing of medicines to the public. History of being a member of a national professional body/organization relevant to the field of the development, manufacture and control of medicines.
Skills:
Excellent knowledge and credibility of practical experience with WHO GMP or equivalent guidelines and their implementation. Extensive and internationally acknowledged experience with conducting GMP inspections. Working knowledge of Good Clinical Practice (GCP) inspections. Excellent knowledge of international medicines regulation and cooperation arrangements, especially regulatory issues pertaining to GMP inspections. Ability to represent and negotiate on regulatory and technical matters at an international level. Good communication and teaching skills. Good professional drafting skills and the ability to work and produce results under time pressure.
WHO Competencies:
1. Producing results,
2. Moving forward in a changing environment,
3. Knowing and managing yourself, and
4. Communicating in a credible and effective way.
Experience:
Essential: At least ten years' experience conducting GMP inspections as a Senior Inspector in a national regulatory agency within an International Conference on Harmonization (ICH) or associated country, including at least five years' experience in leadership and raporteurship roles on technical matters, including training inspectors and evaluating their performance through observed inspections and audits. At least 5 years of international inspectional experience including in developing countries.
Desirable: Ability to represent and negotiate on regulatory and technical matters at an international level. Good communication and teaching skills. Good professional drafting skills and the ability to work and produce results under time pressure.
Languages:
Expert knowledge of English required. A beginners knowledge of French desirable.
Additional Information:
The following priority order will be observed in the screening of candidates: 1. WHO staff members (Continuing, Fixed-term and Temporary appointments), and 2. External candidates.
Other similar positions at the same grade level may be filled from this vacancy notice.
This vacancy is published in English only.
Annual salary:
(Net of tax)
US$80,734 at single rate
US$86,904 with primary dependants
Post Adjustment:
103.3 % of the above figure(s). This percentage is to be considered as indicative since variations may occur each month either upwards or downwards due to currency exchange rate fluctuations or inflation.
A written test may be used as a form of screening
Online applications are strongly encouraged to enable WHO to store your profile in a permanent database. Please visit WHO's e-Recruitment website at: www.who.int/employment . The system provides instructions for online application procedures.
All applicants are encouraged to apply online as soon as possible after the vacancy has been posted and well before the deadline stated in the vacancy announcement.
WHO is committed to workforce diversity.
Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual. Only candidates under serious consideration will be contacted.
WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
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