WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.
Post: Technical Officer
OBJECTIVES OF THE PROGRAMME :
The main objective of the WHO Prequalification of Medicines Programme (PQP) is to assure the quality of medicines supplied through international procurement agencies. This is achieved by: Prequalifying priority essential medicines and monitoring their quality through sampling and testing. Increasing capacity to produce medicines of good quality, facilitating the development of national regulatory processes and increasing capacity to carry out quality control of medicines in recipient countries. Developing and updating global norms and quality standards, needed for the production and regulation of medicines with assured quality.
Description of duties:
- To review, update and establish prequalification requirements, guidelines, procedures and related quality assurance systems with the primary focus on inspection-related matters.
- To plan, manage and coordinate inspection-related activities with the aim of carrying out necessary inspections according to defined timelines, and to help formalize and finalize inspection reports and communications to interested and participating manufacturers and suppliers.
- To be in contact with National Drug Regulatory Authorities/Inspectorates in order to compose teams for the inspections and exchange inspection related information as necessary.
- To participate, as needed, in inspections of manufacturers, quality control laboratories and contract research organizations.
- To ensure consistency of inspections carried out in accordance with the WHO established norms and standards and internal standard operating procedures of the prequalification programme.
- To contribute to PQPs capacity building and training activities, as needed.
- To represent PQP at an international level, mainly on Guidelines for Pharmaceuticals (GMP) and other technical matters.
- To contribute to the improvement of the prequalification programme in general and the inspection part in particular, for the overall coordination and timelines of inspection-related activities and proper record keeping.
- 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.
- 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 & Pharmaceutical Policies/Quality Assurance and Safety: Medicines (EMP/QSM) according to the technical competence (GMP and quality assurance related issues).
- To liaise with other staff members in QSM, EMP and other relevant WHO departments in relation to prequalification issues of medicines for priority diseases.
- To contribute and assist in the review, update and maintenance of a documented quality system.
- To liaise with PQP's partners and stakeholders.
- To participate, in cooperation with other staff in other activities related to the quality,
safety and efficacy of medicines, including by participating in relevant meetings and giving professional advice.
- To assist in the budgetary aspect of the inspection-related activities.
Education:
Essential: Advanced university degree in medicine, pharmacy or chemistry.
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Skills:
Well established knowledge of, and practical experience with, WHO GMP or equivalent guidelines and their implementation. Extensive experience with conducting GMP inspections. Working knowledge of Good Clinical Practice (GCP) inspections. A good knowledge of medicines regulation in ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and associated countries, especially regulatory issues pertaining to GMP. A good knowledge of international regulatory trends and cooperation arrangements. Ability to represent and negotiate on regulatory and technical matters at an international level. Good communication and teaching skills. Managerial skills. Good professional drafting skills and the ability to work and produce results under time pressure. Good medical writing skills in English. Established experience in managing groups of professionals.
WHO Competencies:
1. Fostering integration and teamwork,
2. Building and promoting partnerships across the Organization and beyond,
3. Creating an empowering and motivating environment,
4. Producing results, and
5. Moving forward in a changing environment.
Experience:
Essential: At least ten years' experience conducting GMP inspections as a Senior Inspector in a national regulatory agency within an ICH or associated country. At least three years' experience in a leadership role on technical matters, including training inspectors and evaluating their performance through observed inspections.
Desirable: Working experience in the prequalification of medicinal products and associated capacity building and training activities. Experience working in an international environment including in developing countries.
Languages:
Expert knowledge of English required. 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.
Annual salary: (Net of tax)
US$80,734 at single rate
US$86,904 with primary dependants
Additional Information:
Experience: Min. 10 Years
Location: Geneva, Switzerland
Industry Type: Pharma/ Biotech/Clinical Research
Duration of contract: One year
Vacancy Notice No: HQ/13/QSM/FT323
End Date: 21th Aug, 2013
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