Consultant for conducting Training on Good Manufacturing Practices (GMP)

Consultant for conducting Training on Good Manufacturing Practices (GMP) in Nepali pharmaceutical industries.

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.

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 for Consultant (2 positions) to conduct Good Manufacturing Practices (GMP) trainings in support of PQM+ program implementation in Nepal.

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 on GMP aspects. The trainer/the Consultant will work alongside the technical team of PQM+ to oversee the desired training at different locations in Nepal scheduled on March-April 2021. USP, PQM+ will provide needed logistics and other support to the trainer/consultant and participants of the training. The duration of each training will be 2 days and total level of effort (LOE) will be based upon the number of training delivered including travel and report.

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) per training 

• Training delivery including training schedule, pre- and post-assessment (2.5 days LOE)
• Report preparation and submission (1-day LOE)
• Travel, applicable for out station training (to and from) (maximum of 1.5-day LOE)

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. 
• Excellent communication skills (written and verbal): sensitivity to and responsiveness to participants.
• Excellent analytical skills: mature judgment combined with a proactive, energetic approach to problem-solving.
• Ability to demonstrate highest degree of ethics and integrity.
• Ability to travel to the locations mentioned above. 
• Experience of working in USAID funded program will be preferred.

Application Process:

Eligible consultant/s may submit an Expression of Interest based on the above basic requirements including their consultancy fees per day/ per hour basis, CV, sample of previous work, and copy of PAN/VAT registration certificate. Application should be indicate in the subject “Consultant for GMP Training in Nepal” and submit to usp.nepal@usp.org by 1 March 2021 (5:00 PM). 

Only shortlisted applicants will be contacted for further process.