Scientist (Product Chemistry and Manufacturing)
Vor 7 Tagen
Critères de l'offre
**L'entreprise**: OMS
OMS
Description du poste
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
Under the supervision of the PQT/VCP Team Lead, the Technical Officer/Chemist, is responsible for the following areas of work:
1. Conducting technical reviews, evaluations, and assessments of product chemistry data including the physical and chemical properties and manufacturing process for the products, data supporting the manufacturing specifications and information on the products' formulation which are submitted in the Quality Module of the prequalification dossier. These assessments are included into the prequalification decision with the assessments for product safety and efficacy.
4. Reviewing data and information to support an equivalency determination to an already prequalified product and secondary review of any evaluations done by the Assessors Group on equivalency determinations.
6. Providing information on the product quality assessments and requirements to the PQT/VCP Technical Officer/Case Manager for posting to the web page and serving as the product chemistry expert for vector control products at stakeholder information sessions.
7. Liaising with PQT Inspection Services Group on any product chemistry/composition on final product quality testing; reviewing any incidents reported.
8. Assisting Team Lead at stakeholder meetings, including WHO Vector Control Advisory Group meetings (VCAG) concerning the manufacture and quality of new innovative vector control products.
9. Liaising with Technical Assistance Group on planning and implementation of Collaborative Registration Procedure (CRP) and providing expert advice on product chemistry, manufacturing and product specifications to National Regulatory Authorities (NRAs).
10. Providing input for continual process improvements relating to the review of product chemistry, composition, specifications and manufacturing processes.
11. Coordinating ad hoc expert advisory group on product chemistry issues when needed.
12. Attend the Joint Meeting on Pesticide Specifications (JMPS).Performing other tasks, as required by the PQT/VCP Team Lead or PQT Unit Head.
REQUIRED QUALIFICATIONS
Education
**Essential**:
A first level university degree, and an advanced level degree (Masters level or above) in chemistry (organic or inorganic) or biochemistry.
Experience
**Essential**:
At least seven years of relevant experience of working in industry, government public health agencies, relevant NGOs, and/or national regulatory authorities.
**Desirable**:
1. Experience in collaboration with other UN organizations, agencies, donors and country regulators.
2. Experience of working within a regulatory environment.
3. Experience of working in an industrial capacity in the manufacturer of vector control products or pesticides.
4. Knowledge of the development and/or manufacture of vector control products or pesticide products.
**Skills**:
1. Expert knowledge of product chemistry including physical and chemical properties, formulation development, manufacturing processes and product specifications.
2. Knowledge of standard office software programmes.
WHO Competencies
1. Teamwork
2. Respecting and promoting individual and cultural differences
3. Communication
4. Building and promoting partnerships across the organization and beyond
5. Producing results
Use of Language Skills
**Essential**:
Expert knowledge of English.
**Desirable**:
Beginners knowledge of French.
REMUNERATION
ADDITIONAL INFORMATION
This vacancy notice may be used to fill other similar positions at the same grade level
A written test may be used as a form of screening.
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 a smoke-free environment and does not recruit smokers or users of any form of tobacco.
Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
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