Description:
USP seeks an experienced GMP Coordination Consultant 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 coordinate with Drug Regulatory Authority of Pakistan (DRAP) and support the identification, evaluation, and mapping of potential local pharmaceutical manufacturers capable of manufacturing selected priority medical products in accordance with the checklist and USP technical criteria. The consultant will be responsible for the following activities. This is a remote consulting opportunity and is open for the nationals of Pakistan only.
- Coordinate and collaborate with the DRAP to identify and create a list of potential manufacturers that are registered and currently or have previously manufactured/have the capacity to manufacture selected-priority products.
- Develop criteria for the selection of potential pharmaceutical/health product manufacturers.
- Develop a checklist for technical information required for desktop evaluation of potential manufacturers based on provided checklist and USP technical criteria for desk review.
- Collect and review compliance information, previous inspection reports, and statuses of potential manufacturers using the checklist and USP technical criteria for desk review and determination of manufacturers’ current compliance levels.
- Evaluate the technical data provided by manufacturers against the Mandatory Quality Assurance requirements, including Good Manufacturing Practice (GMP) certification.
- Plan and conduct onsite visits for the selected manufacturer for verification of the data provided by manufacturers.
- Rank manufacturers based on their ability to implement Corrective and Preventive Actions (CAPA) and address gap assessment observations.
- Compile the data and prepare individual files of selected manufacturers.
- Develop a mapping report that includes the assessment of manufacturers' capabilities, compliance status, and ability to address the gaps for improving GMP compliance.
- Prepare project report that includes findings and recommendations.
MANDATORY DELIVERABLES
- A comprehensive list of potential pharmaceutical manufacturers in Pakistan that are registered with DRAP and have the capacity to produce selected-priority medical products.
- Finalized selection criteria and checklist
- Documentation of communications and follow-ups with manufacturers for timely data collection.
- An evaluation report of the technical data collected from manufacturers, including compliance with UNICEF/WHO quality standards
- Report on findings and recommendations
- A detailed mapping report of selected manufacturers, including their current compliance status with Mandatory Quality Assurance requirements and Good Manufacturing Practice (GMP) Certification.
- A ranking of manufacturers based on their readiness and capacity to meet UNICEF/WHO quality standards.
- Project final report.
Mode: Documents and Invoice for the Programmatic Deliverables.
QUALIFICATIONS
- Bachelor’s degree in pharmacy, chemistry, or related field; a higher degree will be an advantage.
- At least 10 years of experience in pharmaceutical regulatory affairs, with a strong understanding of DRAP regulations and UNICEF/WHO quality standards. Experience in the Pakistani pharmaceutical market is highly desirable.
- Familiar with the WHO prequalification process for priority products.
- Detailed experience and knowledge about regulation and manufacturing of Pharmaceuticals.
- Good communication and writing skills.
- Hands-on experience in regulatory inspections and audits.
- Good recognition and connections in pharmaceutical industry and DRAP.