PERIOD OF PERFORMANCE
The scope of the work defined herein should be implemented before April 10, 2024, with an estimated start date in mid-January.
ROLE OVERVIEW:
USP seeks an experienced GMP Expert, based in Pakistan, with extensive experience auditing pharmaceutical manufacturers’ quality management systems to support the implementation of technical activities for a potential upcoming donor-funded opportunity in Pakistan. The consultant will work to provide support for the identification and evaluation of potential local manufacturers after the collection of data. The consultant will be responsible for the following activities.
1. Coordinate with the Drug Regulatory Authority of Pakistan (DRAP) and local manufacturers to collect data on DRAP-registered manufacturers of UNICEF-priority products.
2. Develop criteria for the selection of potential pharmaceutical/health product manufacturers.
3. Develop a checklist for technical information required for desktop evaluation of potential manufacturers based on provided checklist and USP technical criteria for desk review.
4. Collect compliance information from potential manufacturers using the provided checklist and USP technical criteria for desk review.
5. Evaluate the provided information to develop a mapping of selected manufacturers.
6. Conduct onsite visits for the selected manufacturer for verification of the provided information.
7. Rank manufacturers for phase-wise capacity building based on their ability to implement Corrective and Preventive Actions (CAPA) and address gap assessment observations.
8. Compile the data and prepare individual files of selected manufacturers.
9. Prepare project report that includes findings and recommendations.
MANDATORY DELIVERABLES
Deliverable No.
Deliverable Description
Mode
1.
A comprehensive list of DRAP-registered manufacturers capable of producing UNICEF-priority medical products.
Documents And Invoice for the Programmatic Deliverables
2.
Finalized Selection criteria and checklist
3.
A detailed mapping report of selected manufacturers, including their current compliance status with UNICEF Mandatory Quality Assurance requirements and Good Manufacturing Practice (GMP) Certification.
4.
A ranking of manufacturers based on their readiness and capacity to meet UNICEF quality standards.
5.
Project final report
Qualifications
1. Master’s degree in pharmacy, chemistry, microbiology, or related field; a higher degree will be an advantage.
2. Demonstrated ability and aptitude to develop quality management systems and assessing the competence of manufacturer conforming to international best practices of ISO 9001,15189, 13485, 17025.
3. At least 10 years of experience in regulatory inspection for implementation of Good Manufacturing Practices (GDP), Good Distribution Practices (GDP), Good Storage Practices (GSP), and good laboratory practices (GLP) norms in related fields.
4. Experienced on WHO prequalification process for priority products.
5. Detailed experience and knowledge about regulation and manufacturing of Pharmaceuticals and knowledge about Pakistani regulations will be added advantage.
6. In depth knowledge about WHO, ICH and PIC/S guidelines on quality risk management and risk-based approaches.
This is a remote consultancy, open to Pakistani nationals only.
Please send CV, 3-References, and Hourly Rate in US $ to gph_procurement@usp.org by the closing date of January 17, 2024 at 05:00 PM EST. When submitting your application, write “Good Manufacturing Practice (GMP) Consultant” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medical products and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
