Consultant - Quality Management Systems (QMS) at World Health Organization

Purpose of consultancy

The consultant will develop standard operating procedures (SOPs) for specific areas of work carried out by the Department of Regulation and Prequalification (RPQ), as well as an iLearn training module on the Quality Management System for the Department and training materials on QMS implementation for national regulatory authorities.

Deliverables

Deliverable 1: Materials developed for workshop on implementation of quality management systems for national regulatory authorities, in accordance with WHO Technical Report Series 1025 Annex 13.

Deliverable 2: Finalized overviews of quality management system documents required for each team within the RPQ Department.

Deliverable 3: Standard operating procedures (SOPs) for specific work carried out within the RPQ Department, as listed below:

• Draft cross-cutting SOP on managing incidents reported to the RPQ department.
• Finalized SOP on providing technical assistance to manufacturers and clinical research organizations.
• Finalized SOP on working with the European Medicines Agency in the Medicines for all (M4All) programme.
• Finalized SOP on managing the Collaborative Registration Procedure for medicines, vaccines and in-vitro diagnostics.
• Finalized SOP on peer audits at National Quality Control Laboratories.
• Finalized SOP on managing technical dossiers and product samples of medicines.

Deliverable 4: Provide technical input to QMS focal points within the Prequalification Unit in transposing existing SOPs into the new Quality Management System.

Deliverable 5: Develop an expanded iLearn module on the RPQ Department’s Quality Policy and Quality Manual and new iLearn module on RPQ Department’s Quality Management System for new and current staff. 

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced university degree (Masters level or above) in Pharmacy, Pharmaceutical Sciences, Engineering or any other relevant field for Quality Management Systems.

Desirable: 

• Training in Quality Management Systems ISO9001 or any other relevant Quality Management System.

Experience

Essential:

• Over ten years of relevant experience working within Quality Management Systems – out of which five years’ experience in Quality Management Systems in a UN Organization, International Organization, Health Products Industry or National/Regional Regulatory Authority.

Desirable: 

• Experience working on Quality Management Systems in industry and relevant regulatory bodies (regulatory authority/WHO listed authority). 

Skills/Knowledge:

• Strong skills and knowledge in the field of quality management and systems.
• Excellent written and verbal communication skills, strong planning and organizational skills.  
• Strong knowledge and skills in the field of policy and strategy development.
• Demonstrated ability to work as part of a team and in diverse cultural settings. 

Closing Date : Nov 12, 2022