Consultants - Chemistry, Manufacturing and Controls (CMC) at World Health Organization (WHO)

Deliverables

• Produce timely assessment reports (AR) of the reviewed information.
• Report on critical, major, and other deficiencies detected during the review of the documentation/data (assigned to the consultant)
• Assess the applicant's responses to queries raised in the AR and decide on the adequacy of each response. Several sets of queries may be necessary.
• Provide WHO with a recommendation and final remarks on the evaluation based on the documentation assigned for review to the consultant. This should be based on the most updated scientific and regulatory grounds. 

Qualifications, experience, skills and languages
Educational Qualifications:
Essential:

• Advanced university degree in medicine, biology, pharmacy or microbiology.  

Desirable:

• A postgraduate degree in biostatistics. 

Experience
Essential:

• Over ten years’ experience in the pharmaceutical field.
• Extensive experience in the area of CMC of vaccines including the understanding of Quality Systems.
• Experience in the regulation, manufacturing and control of vaccines, and ability to work in a complex international environment.
• Experience in monitoring of regulations and regulatory systems of NRAs, including lot release, manufacture and laboratory good practices, laboratory access, post-marketing surveillance (quality aspects) and other activities like writing regulatory procedures. 

Desirable: 

• Participation in WHO evaluations of NRA and vaccine manufacturers as well as in other WHO activities.

Skills:
Essential:

• Expert must have technical skills and knowledge on the development, strengthening and monitoring of regulatory systems for vaccines, drugs, biologicals, and medical devices.  

Desirable:

• Familiarity with WHO prequalification procedure, with WHO activities in strengthening the capacity to regulate clinical trials, vaccines as a biological medical product and /or with the NRA assessment procedure.

Languages required:
Essential:  

• Expert knowledge of English.