Consultant for Conducting Training on Good Manufacturing Practices (GMP) in Nepal
The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.
USP is seeking an international/regional consultant who will travel to Nepal to conduct Good Manufacturing Practices (GMP) trainings in support of PQM+ program implementation in Nepal to train personnel in regulatory system and manufacturing industries.
Must be willing to travel.
Work details:
The trainer/consultant’s role is to conduct Good Manufacturing Practices (GMP) trainings to technical personnel (pharmacist, chemist, microbiologist) involved in manufacturing, quality control, quality assurance and research & development and logistics management in Nepali pharmaceutical industries and regulatory affairs on GMP aspects. The trainer/the Consultant will work alongside the technical team of PQM+ along with local consultant to oversee the desired training at 3 different locations (Kathmandu, Birgunj, Chitwan) for industrial personnel and 1 (Kathmandu) for regulatory personnel in Nepal.
The training is scheduled on April-May 2021. The duration of each training will be 3 days and total level of effort (LOE) will be based upon the number of training delivered including travel and report. USP, PQM+ will provide needed logistics and other support to the trainer/consultant.
Deliverable:
· The trainer/consultant will be responsible to prepare training schedule in consultation with USP technical team.
· Develop questionnaire for Pre and post training assessment and conduct the assessment.
· The trainer/consultant will be responsible to provide trainings on Good Manufacturing Practices (GMP) based on approved USP curriculum.
· Prepare and finalize the training report.
Expected Level of Effort (LOE)
22 days LOE
· Training delivery including training schedule, pre- and post-assessment (3 days LOE per training)-12 days LOE for total trainings.
· Report preparation and submission (2-day LOE)
· International travel and acclimatization in local atmosphere (maximum of 5-days LOE).
· Local travel; ex-station: 1.5 days LOE (total 3 days for two locations out of Kathmandu)
Basic Qualifications
· Master’s degree in pharmacy, chemistry, microbiology, or related field; a higher degree will be an advantage.
· At least 10 years of experience in GMP/GLP or regulatory environments.
· Experience in establishing compliance with quality systems within pharmaceutical manufacturing companies.
· In-depth knowledge on WHO-GMP, National GMP or other international guidelines like PIC/s, US FDA EU-GMP standards/guidelines.
· Knowledge of and experience with the WHO Prequalification of Medicines Program.
Application Process:
Eligible consultant/s may submit an Expression of Interest based on the above basic requirements including their consultancy fees per day, curriculum vitae, and sample of previous work. Application should be indicate in the subject “Consultant for GMP Training in Nepal” and submit to usp.nepal@usp.org by 07 April 2021 (5:00 PM) deadline.
Only shortlisted applicants will be contacted for further process.
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
