Quality Control Specialist

Job Posting Organization:
The Access to Medicines and Health Products (MHP) Division of the World Health Organization (WHO) is dedicated to improving access to essential medicines and health technologies that are of assured quality, safety, and efficacy. The division collaborates with various United Nations organizations, international partners, expert networks, and WHO Collaborating Centres. It operates within the framework of Universal Health Coverage and focuses on various health programs including HIV/AIDS, TB, malaria, non-communicable diseases, and maternal and child health. The Norms and Standards for Pharmaceuticals Team is one of eight teams in the MHP Division, aiming to assure the quality and safety of health products through the establishment of global norms and standards.

Job Overview:
The Quality Control Specialist will be responsible for planning and coordinating activities related to the elaboration and revision of International Pharmacopoeia texts. This includes managing work plans in consultation with the Expert Advisory Panel and advising on the development of quality control specifications for medicines. The role involves collaboration with WHO Expert Advisory Panels to support the development and promotion of monographs on priority medicines and active pharmaceutical ingredients. The specialist will also support proficiency tests for national drug control laboratories and disseminate information on study results. The position requires maintaining contacts with scientific professionals and regulatory authorities, as well as coordinating with WHO Collaborating Centers to develop standards for quality control of pharmaceuticals.

Duties and Responsibilities:

• Plan and coordinate activities for the elaboration and revision of International Pharmacopoeia texts, managing the work plan in consultation with the Expert Advisory Panel.
• Advise and prepare supporting texts for the development of quality control specifications for medicines.
• Collaborate with WHO Expert Advisory Panel to support the development and promotion of monographs on priority medicines and active pharmaceutical ingredients.
• Prepare and review specifications and background papers for WHO Expert Committees on Specifications for Pharmaceutical Preparations.
• Support proficiency tests for national drug control laboratories through preparation of test protocols and evaluation of results.
• Disseminate information on EQAAS studies and facilitate follow-up actions with quality control laboratories.
• Develop and maintain contacts with scientific professionals and regulatory authorities.
• Coordinate with WHO Collaborating Centers to develop standards for quality control of pharmaceuticals.
• Perform all other related duties as assigned.

Required Qualifications:

• Advanced University degree (Masters level or above) in Pharmaceutical Sciences, Pharmacy, or analytical chemistry.
• At least seven years of experience in the development of pharmaceutical specifications.
• At least five years of hands-on experience in a quality control laboratory using pharmacopoeia specifications.
• Experience in drafting and editing technical quality control texts and preparation or evaluation of marketing authorization applications for pharmaceuticals.
• Desirable: Experience in an international environment and in quality control functions at national, regional, or international levels.

Educational Background:
Essential: Advanced University degree (Masters level or above) in Pharmaceutical Sciences, Pharmacy, or analytical chemistry. Desirable: PhD in Pharmaceutical Sciences or analytical chemistry.

Experience:
The position requires at least seven years of experience in the development of pharmaceutical specifications and at least five years of hands-on experience in a quality control laboratory. Candidates should have experience in drafting and editing technical quality control texts and preparing or evaluating the quality part of marketing authorization applications for pharmaceuticals. Experience in an international environment and in quality control functions at various levels is desirable.

Languages:
Essential: Expert knowledge of English. Desirable: Intermediate knowledge of French.

Additional Notes:
The position offers a competitive salary starting at USD 84,672, with additional benefits including 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children. The WHO is committed to diversity and encourages applications from women, persons with disabilities, and nationals of underrepresented Member States. Candidates may be required to provide proof of vaccination as per WHO requirements before undertaking assignments. The organization promotes a smoke-free environment and does not recruit smokers or tobacco users.