Position Summary:

The Technical Specialist, Procurement Services Branch position is located in the UNFPA office in Copenhagen. The incumbent will perform under the direct supervision of the Chief and Deputy Chief, Procurement Services Branch in Copenhagen and in close working relationship with the UNFPA Technical Division (New York), UNFPA Regional Offices, UNFPA Country Offices and WHO (World Health Organization).

Responsibilities:

Prequalification of male and female condoms from manufacturers worldwide

·        To be the project manager for UNFPA in the implementation of the WHO/UNFPA prequalification programme for male and female condoms.

·        Screen review dossiers (Product Dossiers, Site Master Files) and conduct factory inspections with technical experts to prequalify products and manufacturing sites.

·        Assist in reviewing, updating and establishing prequalification requirements, guidelines, procedures and related quality assurance systems for the assessment of factories manufacturing male and female condoms, based on existing WHO and UNFPA norms, standards and guidelines and other existing regulatory guidance documents, when appropriate.

·        Be responsible for managing the Technical Review Process for female condoms in close collaboration with WHO.

·        Be in contact with National Regulatory Authorities and other relevant professional organizations in order to arrange the inspections of factories according to the WHO and UNFPA prequalification guidelines.

·        Assist in the research of information relevant to the Prequalificationprogramme, to prepare reports and present feedback, data and results, including training materials in the areas of work and competence.

·        Contribute to training workshops organized by WHO or UNFPA.

·        Cooperate with other staff members in UNFPA PSB Copenhagen, UNFPA Head Quarters Technical Division, Regional Offices and Country Offices, WHO Geneva and other relevant departments in relation to prequalification issues by helping to prepare necessary background materials and briefing notes.

Quality control analysis of Condoms

·        Be responsible for liaising with quality control laboratories, testing facilities for the testing of samples and finalization of respective reports.

·        Ensure that the content of the Laboratory Information Files (LIF) and Standard Operation Procedures (SOP), for laboratories performing quality control analyses of condoms is in accordance with the WHO/UNFPA prequalification programme and UNFPA established norms and standards and internal Standard Operating Procedures (SOPs).

·        Be responsible for the evaluation of the LIFs of laboratories which have expressed an interest in being pre-qualified for the quality control analyses of condoms for UNFPA procurement.

·        Organize the assessment and inspection of these laboratories which have applied for prequalification according to the established guidelines and procedures, including finalizing the respective reports.

·        Be responsible for the organization of quality control analyses of samples of condoms.

·        Liaise with other professional staff in the Prequalification programme in order to assist in product testing and laboratory quality control-related issues.

·        Liaise with the quality control laboratories that have been assigned to carry out the quality control analyses for the Programme and to ensure that high quality reports on the contracted-out work are produced.

·        Monitor quality and analyse the performance of the manufacturers who hold Long Term Agreements (LTAs) with UNFPA through the pre-shipment test results and post shipment results.

Operational Procedures and related documentation

·        Draft and finalize the SOPs concerning the prequalification programme for male and female condoms.

·        Draft and finalize the SOPs concerning the specific areas of quality control laboratory activities.

·         Assist in creating, as required, any additional SOPs for the assessment of product dossiers and SMFs provided by the manufacturers, and other related SOPs and guidelines as appropriate to the Prequalification programme.

·        Contribute and assist in the review, updating and maintenance of a documented quality system for the WHO Prequalification programme of condoms

·        Assist, upon need, in liaising with other staff members in WHO Geneva in the development, implementation and review of any relevant guidelines.

·        Provide technical lead in the updating and revisions of technical specification guideline documents  and technical documents with WHO, manufacturers and key stakeholders

Requirements:

Education:

Masters degree in pharmacy, chemistry, medicine, engineering, public health or biology, with considerable experience in condom quality, research or manufacturing. University degree in a related field or recognized national certification or equivalent professional experience essential.

Knowledge and Experience:
• Seven years of experience in quality, scientific or technical work with contraceptive devices or experience of quality related and regulatory work with health products.
•  Sound knowledge of the quality control of medical devices and of quality control laboratories.
• Good general knowledge of regulatory work in the area of quality of medical devices

Languages: Fluency in English is required. Working knowledge of another official UN language is desirable.