Local Pharmaceutical Manufacturing Support Consultancy (Multiple Tasks) – Kenya at US Pharmacopeia

Purpose & Nature of Assignment

The consultant shall perform an assessment of the policy, legal and regulatory (PLR) landscape relevant to the project, support the client in the process of identification, sourcing, negotiating, and structuring relevant technology transfer, intellectual property (IP), and/or licensing agreements and support the client achieve WHO-Prequalification status. The assignment requires subject matter expertise in technical, operational, and administrative functions in the manufacture of pharmaceuticals including vaccines. A consultant with this background will represent USP on this project while being supported by technical staff within the Kenyan office and Rockville-Headquarters. There will be local trips within Nairobi and environs with potential for international travel.

The consultant will complete the following tasks

1. Policy, Legal and Regulatory Review
2. Assess vaccine related policies, legal and regulatory situation in Kenya and the East African Community (EAC) as related to WHO requirements. 
3. Identify gaps/inconsistencies and anticipated challenges related to vaccines market.
4. Analyze the existing and expected regulatory framework governing vaccines at local, regional, and continental levels.
5. Assess gaps between Kenya Pharmacy and Poisons Board and WHO standards for WHO-Prequalification.
6. Recommend draft legislation/regulation/guidelines based on international best practices relevant to the project.
7. Recommend regulatory implementation and/or capacity building to enable the project.
8. Cite and advise on relevant requirements and regulations to construct and operate a vaccine manufacturing facility.
9. Cite and advise on requirements related to the import and export of vaccines and vaccine related materials.
10. Cite and advise on policies or regulations related to local suppliers, local (private & public) and EAC states procurement of vaccines.
11. List required permits, certifications, or other legal requirements to achieve WHO Prequalification status.
12. Cite requirements related to Good Manufacturing Practices (GMP) and technology transfers.
13. Propose a monitoring and evaluation (M&E) plan to support implementation and tracking of the recommendations.
14. Support other tasks in the project by providing information and subject matter expertise.

B. Technology Transfer Agreements

1. Develop a summary of specific technologies to be transferred, from whom, and under what terms and conditions.
2. Develop a set of draft or completed technology transfer agreements for all technology transfers for the project.
3. Develop a detailed cost analysis, obligations and/or liabilities related to the relevant technology transfers.
4. Develop an analysis of issues, challenges and recommendations related to technology transfers.
5. Propose a monitoring and evaluation (M&E) plan to support implementation and tracking of the recommendations.
6. Support other tasks in the project by providing information and subject matter expertise.
7. WHO Prequalification (WHO PQ)
8. Conduct detailed mock audit/ WHO-PQ facility audit, highlight deficiencies, and make recommendations.
9. Conduct detailed Kenyan Pharmacy and Poisons Board (PPB) capacity audit to support facility WHO PQ, highlight any deficiencies and make recommendations.
10. Participate in site visits with WHO inspectors when possible.
11. Support post-approval site visit follow-up actions e.g., Corrective and Preventative Actions (CAPA).
12. Propose a monitoring and evaluation (M&E) plan to support implementation and tracking of the recommendations.
13. Support other tasks in the project by providing information and subject matter expertise.

Required Education and Experience

1. Bachelor’s degree in the areas of pharmacy, pharmaceutical manufacturing, chemistry, or related fields. Post-qualification training in pharmaceutical policy, pharmaceutical production, research and development, project management, business management or any relevant field will be an added advantage.
2. Minimum 10 years’ hands-on experience in pharmaceutical production, Quality Management Systems, technical & administrative operations and GMP compliance in finished pharmaceutical product manufacturing facilities.
3. Good understanding of the WHO standards pharmaceutical manufacturing environments.

4.     Experience in technical cooperation arrangements/ consultancies.

Preferred Experience

1. Experience in vaccine production/ regulation.
2. Demonstratable experience in previous similar assignment(s).

Knowledge, Skills, and Abilities

1. Possess managerial and good communication skills
2. Project management skills
3. Excellent analytical and report writing skills
4. Good personality skills
5. Results-driven with demonstrated successful outcomes
6. Must be proficient in the use of Microsoft office suite (word processing, email, spreadsheet, database, and Internet)
7. Effective team player, and experience with short term project implementation at national and local levels

Deliverables

The consultant shall prepare and deliver to USP, on behalf of the client;

1. Detailed final report of Policy, Legal and Regulatory Review and other tasks which includes all findings, analyses, recommendations, and a proposed M&E plan.
2. Detailed final report of Technology Transfer Agreements and other tasks which includes all findings, analyses, recommendations, and a proposed M&E plan.
3. Detailed final report of WHO Prequalification and other tasks which includes all findings, analyses, recommendations, and a proposed M&E plan.