• Country: Geneva, Switzerland
• No of vacancies: N/A
  
• Salary: N/A 
• Organization: WHO
• Gender: Both 
• Deadline: 2024-02-01

DESCRIPTION OF DUTIES

1. Participates in planning, management and coordination of assessments of biotherapeutic products carried out in the WHO Prequalification Unit’s Medicines Assessment Team.
2. Provides technical assessment and evaluation of submitted dossiers from pharmaceutical manufacturers with respect to quality.
3. Manages, coordinates and monitors assessments done by internationally based assessors. Liaises, coordinates and communicates with pharmaceutical manufacturers on dossiers submitted for prequalification.
4. Creates and maintains standard operating procedures, guidelines and related quality assurance systems for PQT.
5. Provides expert advice on technical issues related to quality issues of medicines as well as providing technical expertise in relevant meetings and Expert Advisory groups.
6. Performs all other related duties as assigned.

REQUIRED QUALIFICATIONS

Education

Essential: Advanced level University degree in biology or related health science such as biotechnology.
Desirable: PhD in a related field.

Experience

Essential: At least seven years of working experience as a national and international assessor of the quality part, including monoclonal antibodies and insulin related products.
Desirable: Experience of GMP inspections of biotherapeutic and biosimilar product manufacturing sites. Hands-on experience in dealing with the quality aspects of marketing authorizations of BTPs. Extensive knowledge of prequalification procedures and WHO guidelines on BTP/SBPs.

Skills

• Scientific background, particularly in the area of BTPs.
• Knowledge of production and quality control of BTPs.
• Extensive knowledge of Good Manufacturing Practices.
• Sound knowledge of regulatory affairs.
• Proven ability to write technical reports.
• In depth understanding of the BTP industry.

WHO Competencies

1. Teamwork
2. Respecting and promoting individual and cultural differences
3. Communication
4. Producing results
5. Moving forward in a changing environment

Use of Language Skills

Essential: Expert knowledge of English.
Desirable: Intermediate 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 77,326 (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 5368 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.

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