Consultant – Quality Management Systems (QMS), Anywhere

  • Contractor
  • Anywhere

World Health Organization (WHO)

Consultant

Quality Management Systems (QMS)

( 2209841 )

Contractual Arrangement : External consultant

Contract Duration (Years, Months, Days) : 6 months

Job Posting: Oct 28, 2022, 10:57:30 AM

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.

Background

The objective of the work is to develop an overview of the quality management system documents required for the teams within the Prequalification Unit, Regulation and Safety Unit and Local Production and Assistance Unit of the Department of Regulation and Prequalification. The SOPs as listed below for specific areas of work undertaken by the Units will also be developed. This work will contribute to the full implementation of the QMS across the Department.

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.

Languages required:

Essential:

  • Expert knowledge of English.

Desirable:

  • Intermediate Knowledge of other UN languages.

Location

Off site: Home-based

Travel

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level C-USD 10,000-12,500 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

6 months.

Additional Information

  • This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
  • Only candidates under serious consideration will be contacted.
  • A written test may be used as a form of screening.
  • If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: (link) Some professional certificates may not appear in the WHED and will require individual review.
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  • WHO is committed to workforce diversity.
  • 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.
  • 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 zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
  • Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
  • WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
  • Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: (link)-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html