WHO is the United Nations’ specialized agency for Health. It is an inter-governmental organization and works in collaboration with its member states usually through the Ministries of Health. WHO’s objective is the attainment by all people of the highest possible level of health. WHO's Secretariat is staffed by health professionals, other experts and support staff working at headquarters in Geneva, six regional offices and country offices.
Post: Technical Officer
OBJECTIVES OF THE PROGRAMME :
To optimize WHO'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:
To participate as a WHO staff member in inspections of the manufacturers of the finished dosage forms and, upon need, to carry out inspections for active pharmaceutical ingredient manufacturers and contract research organizations. Working within the established programme work plan , manage and coordinate inspection-related activities of the prequalification process with the aim of carrying out necessary inspections within the shortest possible timelines, and to 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. 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 the improvement of the Prequalification Programme in general, and the inspection element in particular, for the overall coordination and timeliness of inspection-related activities and proper record keeping. To undertake 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 participate in training workshops organised by the programme for stakeholders according to their general and specific specialist technical competences (Good Manufacturing Practices (GMP) and quality assurance related issues). To establish, review, update and implement prequalification requirements, guidelines, procedures and related quality assurance systems for the assessment and inspection of quality, safety and efficacy of the priority medicines, based on existing relevant WHO (and related) norms, standards and guidelines and other existing regulatory guidance documents, when appropriate, with specific focus on (but not limited to) Active Pharmaceutical ingredients and finished pharmaceutical products. To liaise with other staff members in the Essential Medicines department and other relevant departments in relation to prequalification issues of medicines for priority diseases, including but not limited to HIV/AIDS, malaria and tuberculosis, by preparing necessary background materials. To liaise with quality control laboratories for the testing of samples and finalization of respective reports. To compose, upon need, inspection and assessment teams for quality control laboratories.
OPERATIONAL PROCEDURES AND RELATED DOCUMENTATION
To review, update and maintain a documented quality system for the Prequalification Programme. To liaise with Prequalification Programme partners and stakeholders. To liaise with other staff members from relevant units in WHO for the development, implementation and review of guidelines related to norms and standards.
RELATED ACTIVITIES
To work in cooperation with the Programme's professional and general service staff. To participate in cooperation with other professional staff or Quality Assurance and Safety: Medicines
(QSM) in other activities related to medicines safety, efficacy and quality, mainly by participating in relevant meetings and giving professional advice.
Desired Profile:
Education:
Essential: Master's level university degree in a relevant field of study such as pharmacy, chemistry or microbiology.
Desirable: Studies in pharmaceutical chemistry and/or pharamaceutical technology.
Skills: Good knowledge of Good Manufacturing Practices (GMP) and demonstrated skills in the inspection of Finished Pharmaceutical Products and Active Pharmaceutical Ingredient Evidence of experience in writing pharmaceutical norms and standards.
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: Minimum of 7 years working experience relevant to the position including at least 3 years as a pharmaceutical inspector in a national drug regulatory authority. Experience in performing inspections and writing inspection reports. Several years of international experience.
Desirable: 2-3 years' industrial experience in manufacturing medicines. As the vast majority of the inspections performed by PQ Group Inspectors are currently in China and India, specific experience in one or other and preferably both of these territories is desirable.
Languages:
Excellent knowledge of English required. A basic knowledge of French desirable. Language skills in a relevant regional Chinese and/or Indian language advantageous.
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 level may be filled from this vacancy notice.
This vacancy is published in English only.
Annual salary: (Net of tax)
US$67,483 at single rate
US$72,467 with primary dependants
Post Adjustment: 92.9 % 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.
Additional Information:
Vacancy Notice No: HQ/12/QSM/FT308
Title: Technical Officer
Grade: P4
Contract type: Fixed-Term Appointment
Duration of contract: 1 year
Application Deadline: 17 August 2012
Duty Station: Geneva, Switzerland
Organization unit: HQ/QSM - Quality Assurance and Safety: Medicines (HQ/QSM) /HQ/PQM Prequalification of Medicines Programme (HQ/PQM)
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