Consultant - Good Manufacturing Practice (GMP) for antivenom manufacturing facilities

Purpose of consultancy

• Contribute to the evaluation of the quality, safety, and efficacy of antivenoms produced by various manufacturers. This involves assessment of the products and their suitability for procurement, and evaluation of the performance and proficiency of manufacturers.
• Provide technical expertise and advice on quality management systems and adherence to the World Health Organization (WHO) recommendations of GMP, conduct inspections of the quality management systems for manufacture of antivenoms and contribute to guideline development and training.

Background

Antivenoms are bespoke biological products that have been the mainstay of snakebite treatment for 125 years. Requirements for production, safety and efficacy vary across regulatory environments and shortages of effective antivenoms have emerged as important public health issues, particularly in sub-Saharan Africa, but also in other regions of the world. The variability of current products in this market presents substantial challenges. There are concerns in relation to the safety, efficacy and fitness-for-use of many products exacerbated by a lack of transparent, high-quality, published data. In response, WHO has established a risk-benefit assessment procedure for snake antivenom immunoglobulin preparations that examines data obtained from (a) critical review of product dossiers by independent experts, (b) independent laboratory analysis of antivenoms and immunizing venoms used in their manufacturing, and (c) WHO inspections of manufacturing sites to evaluate compliance with GMP. Risk-benefit assessment is not WHO prequalification. The parameters of the procedures are substantially different. The approach enables WHO to determine whether products have an acceptable risk to benefit ratio sufficient to support procurement in markets where prequalified products are not available, current clinical evidence of antivenom safety and effectiveness is weak, but demand for treatment is high. Where positive risk-benefit relationships exist WHO will recommend products for procurement to the extent supported by the findings of the procedure.

Deliverables

• Deliverable 1: Contribute to the preparation for each on-site inspection: review manufacturer documentation and Standard Operating Procedures (SOPs), review assessment dossiers and list of identified issues and queries to be raised during inspections of the manufacturing sites. Prepare a science and risk-based inspection plan for each company site.
• Deliverable 2: Participate in the conduct of on-site inspection of manufacturing facilities and evaluation of quality management systems and working standards to assess compliance with WHO GMP and other WHO requirements for risk-benefit assessment of snake antivenom products. Contribute to the provision of a summary of findings and recommendations to the company senior management during the inspection and at the exit meeting.
• Deliverable 3: Contribute to the preparation of a written report for each inspection and submit for confirmation with the company.
• Deliverable 4: Participate in the review of the responses to Corrective and Preventive Actions (CAPAs) submitted by the manufacturer after the inspection and to make recommendations to WHO.
• Deliverable 5: Prepare a written inspection summary report and table of recommendations for each product under risk-benefit assessment. Attend online meetings held with Technical Advisory Group – Snake Antivenom Immunoglobulin Listing (TAG-SAIL) and provide expert advice to technical issues raised by the TAG-SAIL in relation to the inspections.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced degree in chemistry, pharmacy, biological sciences relevant to pharmaceuticals, biologicals and vaccines manufacturing and control.

Desirable:

• Post-graduate training in pharmaceutical technology or pharmaceutical analysis.

Experience

Essential:

• Over 10 years of working experience in a senior technical role (e.g., research, production, quality assurance/control, regulatory affairs) within the pharmaceutical, biologicals, or vaccines manufacturing industry and/or its regulation.
• Practical auditing experience that includes the investigation of data integrity, assurance, and management.

Desirable:

• At least 3 years of experience in the inspection of pharmaceutical, biological, or vaccines manufacturers (e.g., as a GMP/GCP/GLP inspector or auditor for 15013485 or 1509001), preferably with an NMRA, Notified Body, or as a specialist adviser to an NMRA or as an independent auditor in PIC/5 or MDSAP participating authorities.

Skills/Knowledge:

Essential:

• Knowledge of GMP/GCP/GLP and/or ISO norms and their practical application.
• Extensive knowledge and expertise related to biologicals manufacturing including laboratory systems and their control as well as senior management responsibility of these activities in a regulated environment.
• Ability to interact extensively with the manufacturers senior management (Heads of Quality Assurance, Production and Quality Control).
• High level professional and technical expertise to assure credibility in the routine interactions and interviews performed.
• Advanced writing skills.
• Knowledge of available tools.
• Ability to work independently and meet timelines consistently.

Languages required:

Essential:

• Expert knowledge of English.

Desirable:

• Knowledge of Arabic or Hebrew.

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:

9 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: 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.
• 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: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html