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Technical Officer, Inspection services

Geneva

  • Organization: WHO - World Health Organization
  • Location: Geneva
  • Grade: Mid level - P-4, International Professional - Internationally recruited position
  • Occupational Groups:
    • Internal audit, Investigation and Inspection
  • Closing Date: Closed

OBJECTIVES OF THE PROGRAMME

The Regulation and Prequalification Department (RPQ) works with Member States and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. RPQ works within the Access to Medicines and Health Products Division (MHP) division departments in the wider framework of Universal Health Coverage and category 4 of the General 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 Sustainable Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres.

DESCRIPTION OF DUTIES

To provide input to the department and team aiming at the highest level of quality, efficacy and safety in the provision of selection and appropriate use of essential health technologies. More specifically the incumbent should, under the supervision of the Team Lead of Inspection Services and in liaison with the Team Lead of Vaccines Assessment:

1. Coordinate the scheduling and conduct, as lead, of GMP inspections of manufacturing lines of vaccines for the Inspection Services team. Evaluate manufacturing premises, processes and procedures and confirm the integrity of the quality of the data. Confirm that the vaccines offered for supply comply with WHO recommendations and UN tender specifications. Ensures that the evaluation of each vaccine is performed within the established timeframe.

2. Prepare inspection reports according to relevant Standard Operating Procedures (SOPs) and coordinates evaluation of Corrective Actions and Preventive Actions (CAPA) plans submitted by the manufacturer in response to the inspection report.

3. Contribute to updating existing SOPs and instructions and developing new ones related to the areas of inspection team.

4. Provide technical advice regarding GMP compliance of vaccines involved in complaints/Adverse Events following Immunisation (AEFIs) and any other issues of concern impacting on the supply of the vaccine through the UN system. Develop systems for investigation and analysis of problems, formulating appropriate responses and preparing information documents on their resolution.

5. Provide technical advice to the procurement arms of the UN agencies concerning manufacturing capacity and continued GMP compliance and other terms and conditions for the international procurement and supply of vaccines.

6. Identify training needs and contribute to the development of appropriate training curricula to beprovided through Global Learning Opportunities (GLO) or other mechanisms.

7. Support the development of Guidance documents to vaccine manufacturers with regard to GMP compliance for prequalification.

8. Provide support for other relevant activities of the vaccines assessment and inspection teams.

9. Contribute to the development of information and documents for PQT web pages in particular those related to prequalification of vaccines including the preparation of WHO Public Information Reports

10. Perform other duties, as assigned by the Team Lead, Inspection Services and Unit Head, PQT.

REQUIRED QUALIFICATIONS

Education

Essential: Advance University degree (Master's level or above) in Biology, Pharmacy, Chemistry, Biochemistry, Medicine, Microbiology, Biotechnology, Bioengineering or related science.
Desirable: Qualified GMP inspector/auditor of a recognized regulatory body (PICS member or ICH country inspectorate).

Experience

Essential:

  1. A minimum of 7 years of professional work experience in the regulation of biological products related to production/control/quality assurance of vaccines and biologicals acquired by working with a vaccine manufacturer or National Regulatory Authority.
  2. Extensive experience at the national level as a vaccine inspector.
  3. Experience in working with developing countries.

Desirable:

  1. Experience at the international level would be an asset.
  2. Familiarity with the WHO prequalification procedure would be an asset.
  3. Work experience in developing countries and work experience in collaborating with industry would be an asset.
  4. Experience in working with in the UN system would be an asset.

Skills

  • Scientific background, particularly in the area of vaccines.
  • Knowledge of production and quality control of vaccines and the manufacturing of sterile products.
  • Extensive knowledge of GMP and of Quality Systems.
  • Sound knowledge of regulatory affairs.
  • Proven ability to interpret technical standards and guidelines and write technical reports, in particular inspection reports.
  • In depth understanding of the vaccine industry.
  • Excellent interpersonal and communication skills, ability to establish and maintain effective working relationships with international and national staff at all levels.
  • Experience, motivation and ability to work in an international environment and in a team.

WHO Competencies

  1. Teamwork
  2. Respecting and promoting individual and cultural differences
  3. Communication
  4. Producing results
  5. Knowing and managing yourself

Use of Language Skills

Essential: Expert knowledge of English.
Desirable: Beginners knowledge of French.

REMUNERATION

WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 75,602 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 4952 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.

ADDITIONAL INFORMATION

  • This vacancy notice may be used to fill other similar positions at the same grade level
  • Only candidates under serious consideration will be contacted.
  • A written test may be used as a form of screening.
  • In the event that your candidature is retained for an interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
  • Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.
  • Staff members in other duty stations are encouraged to apply.
  • WHO is committed to workforce diversity.
  • WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
  • WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
  • WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
  • WHO has a mobility policy which can be found at the following link: http://www.who.int/employment/en/. Candidates appointed to an international post with WHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.
  • Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
This vacancy is now closed.
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