.

Qualifications

Purpose of consultancy

To provide technical expertise in the field of national quality control laboratories.

Background

The Laboratory Networks and Services (LNS) team in the Regulation and Safety (REG) Unit of the Regulation and Prequalification Department (RPQ) is contributing to regulatory systems’ strengthening through facilitating and promoting access to laboratories by:

• Organizing and coordinating laboratory testing as dictated by various needs (e.g. pre/post prequalification, following complaints, quality surveys, support of national regulatory approvals, development of WHO standards and guidelines, resolution of ad hoc issues related to quality of medical products.)
• Assessing compliance of laboratories with required standards e.g. WHO Norms and Standards, WHO Prequalification programme and Global Benchmarking Tool.
• Assisting national control laboratories to achieve technical maturity and/or prequalification through direct technical assistance or other collaboration including audits.
• Building and supporting regional and global collaboration and networks of laboratories
• Initiation and performance of trainings, feasibility, collaborative and proficiency testing studies.

Deliverables

• Deliverable 1 – capacity building of quality control laboratories and related activities.
  • Activity 1.1: Develop technical products (Presentations, guidance documents, training packages…)  for the following activities and areas:
    • Lot release and testing of vaccines.
    • Monitoring of trends and control charts for vaccines, as well as in the context of other pharmaceuticals.
    • Statistical analysis and methods used for the monitoring of trends of vaccines, as well as for other pharmaceuticals.
    • General requirements of the WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL), WHO Good Practices for Microbiological Quality Control Laboratories (GPMQCL) and applicable requirements of WHO Good Manufacturing Practices (GMP).
    • Laboratory safety requirements; and
    • Auditing the Quality Control Laboratories for Biologicals and Pharmaceuticals.
  • Activity 1.2: Contribute and develop guidelines and standards operating procedures in the field of Laboratory Networks and Services activities.
  • Activity 1.3: Contribute to the development of the Laboratory Information Management System.
• Deliverable 2 – strengthening of quality control laboratories and other related activities.
  • Activity 2.1: Organize in country vaccine quality capacity building initiative for best practices (e.g lot release, in vivo testing).
  • Activity 2.2: Enhance quality control laboratories capacities in specific areas, such as Out-of-Specification, Equipment management, Uncertainty of measurement, Reporting of results and Risk assessment and analysis.
  • Activity 2.3: Provide capacity building to specific laboratories.
  • Activity 2.4: Facilitate major LNS meetings, workshops, and capacity building events as per team leaders’ guidance.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• For band level B: Minimum first university degree in pharmacy, chemistry, or biology (and related areas).
• For band level C: Minimum an advanced university degree in pharmacy, chemistry, or biology (and related areas).

Desirable:

• Studies in regulation of medicinal products.

Experience

• For Band level B: 5 to 10 years of relevant experience working in the area of regulation of essential medicines and other health technologies.
• For band level C: over 10 years of relevant experience working in the area of regulation of essential medicines and other health technologies.

The experience was acquired by:

• Working at national or regional regulatory authorities or pharmaceutical/biological manufacturer or other relevant institution.
• Working at National Quality Control Laboratory, performing laboratory testing of vaccines and/or medicines.
• Demonstrated experience in development and delivery of highly technical training curriculum.
• Demonstrated experience in an international context.

Desirable:

• A minimum of 5 years of experience in regulatory inspection processes namely WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL), WHO Good Practices for Microbiological Quality Control Laboratories (GPMQCL) and applicable requirements of WHO Good Manufacturing Practices (GMP), as well as prior experience in providing technical assistance to laboratories in low- and middle-income countries.

Skills:

Essential:

• Strong scientific and technical knowledge in the field of medical products, including norms and standards as well as international guidelines related to the quality control laboratories.
• Good skills in developing training curriculums, writing reports, facilitating, and conducting country visits, workshops, trainings.
• Excellent communication and working in diverse cultural settings.

Languages required:

Essential:

• Expert knowledge of English.

Desirable:

• Intermediate or expert knowledge of any of the other 5 UN languages (Arabic, Chinese, French, Russian or Spanish).

Location

Off site: Home-based.

Travel

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level B – USD 350 – 499 per day or USD 7,000 – 9,980 per month.
Band level C – USD 500 – 625 per day or 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:

1 to 11 months (depending on work assignment).

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: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO’s operations please visit: http://www.who.int.
• The WHO is committed to creating a diverse and inclusive environment of mutual respect. The WHO recruits workforce regardless of disability status, sex, gender identity, sexual orientation, language, race, marital status, religious, cultural, ethnic and socio-economic backgrounds, or any other personal characteristics.
  The WHO is committed to achieving gender parity and geographical diversity in its workforce. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply for WHO jobs.
  Persons with disabilities can request reasonable accommodations to enable participation in the recruitment process. Requests for reasonable accommodation should be sent through an email to reasonableaccommodation@who.int.
• An impeccable record for integrity and professional ethical standards is essential. 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 (https://www.who.int/about/who-we-are/our-values) 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 short-listed candidates.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority.
• WHO shall have no responsibility 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.
• Please note that WHO’s contracts are conditional on members of the workforce confirming that they are vaccinated as required by WHO before undertaking a WHO assignment, except where a medical condition does not allow such vaccination, as certified by the WHO Staff Health and Wellbeing Services (SHW). The successful candidate will be asked to provide relevant evidence related to this condition. A copy of the updated vaccination card must be shared with WHO medical service in the medical clearance process. Please note that certain countries require proof of specific vaccinations for entry or exit. For example, official proof /certification of yellow fever vaccination is required to enter many countries. Country-specific vaccine recommendations can be found on the WHO international travel and Staff Health and Wellbeing website. For vaccination-related queries please directly contact SHW directly at shws@who.int.
  In case the recruitment website does not display properly, please retry by: (i) checking that you have the latest version of the browser installed (Chrome, Edge or Firefox); (ii) clearing your browser history and opening the site in a new browser (not a new tab within the same browser); or (iii) retry accessing the website using Mozilla Firefox browser or using another device. Click the link for detailed guidance on completing job applications: Instructions for candidates.

For roster VNs:

The purpose of this vacancy is to develop a list of qualified candidates for inclusion in this advertised roster. All applicants will be notified in writing of the outcome of their application (whether successful or unsuccessful) upon conclusion of the selection process. Successful candidates will be placed on the roster and subsequently may be selected for consultancy assignments falling in this area of work or for similar requirements/tasks/deliverables. Inclusion in the Roster does not guarantee selection to a consultant contract. There is no commitment on either side.