E-DRUG: PQM Call for GMP and/or GCP Technical Assistance
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www.usp.org<http://www.usp.org/
Promoting the Quality of Medicines (PQM) Program is seeking consultants
and/or businesses for various upcoming assignments throughout the year
entailing overall Good Manufacturing Practices (GMP) and Good Clinical
Practices (GCP) technical assistance to international manufacturers and
clinical research organizations (CROs).
Please see link (and pasted below) for the job description.
https://drive.google.com/file/d/0B3yIA6TC8rhicmpxZ3RjNU4wX0k/view
PQM Call for GMP and/or GCP Technical Assistance
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 (PQM) program is a program funded by
the United States Agency for International Development (USAID) and
implemented by USP. Since 1992, USP has worked in partnership with USAID to
support low and middle income countries in addressing critical issues
related to medicines quality.
The PQM program provides pro bono technical assistance to build capacity of medicines regulatory authorities and quality assurance systems in countries with emergent health systems and it supports manufacturing of quality-assured priority essential medicines for malaria, HIV/AIDS, tuberculosis, neglected tropical diseases, and maternal and child health.
There is increasing recognition of the burden of poor-quality medicines and their threat to public health, especially in low- and middle-income countries. Falsified and substandard medicines can cause treatment failure and adverse reactions, can increase morbidity and mortality, and may contribute to antimicrobial resistance.
These medicines represent not only a waste of scarce resources but also a substantial risk to public health. Further, they risk undermining decades of health
investments, including those made by USAID.
PQM is currently seeking technical assistance in one or more of the
technical areas of interest as listed below. PQM is seeking consultants
and/or businesses for various upcoming assignments throughout the year
entailing overall Good Manufacturing Practices (GMP) and Good Clinical
Practices (GCP) technical assistance to international manufacturers and
clinical research organizations (CROs).
Working under the guidance of PQM program and technical staff,
consultants/businesses will be responsible for carrying out specific tasks
related to GMP, product dossier/regulatory submission document (Chemistry,
Manufacturing, and Controls (CMC)), bioequivalence (BE) studies and/or GCP.
Applications may be made to one or more of the tasks below.
Technical Areas of Interest:
o A: Technical assistance in designing BE studies and interpretation of
study results
- Provide technical assistance by reviewing and advising on BE protocols
submitted by manufacturers/CROs in preparation of BE studies to be
conducted for priority medicines § Provide technical assistance in
analysis and interpretation of BE study data § Conduct trainings on BE
protocol design, review, and analysis
o B: Technical assistance to CROs
- With the PQM staff, plan and conduct audits of clinical research
organizations (CROs) proposed by manufacturers and/or PQM to carry out the
BE studies § Develop audit report to submit to PQM staff § Work with PQM
staff to review and guide the CROs in developing and implementation of the
corrective and preventive action (CAPA) plan § Provide capacity building
training to sponsors and their CROs
o C: Technical assistance to manufacturers of priority pharmaceutical
products on internationally acceptable Good Manufacturing Practice (GMP)
standards and dossier/CMC compilation
- Plan and conduct GMP assessments of pharmaceutical manufacturing
facilities
- Develop audit report to submit to PQM staff
- Provide assistance to pharmaceutical manufacturers in developing and implementation of CAPA plans
- Provide capacity building training to staff of manufacturers on GMP topics and dossier/regulatory submission documents
- Provide assistance to manufacturer staff on compiling regulatory documents
for submission
- Review regulatory documents prior to submission
o D: Technical assistance to manufacturers of priority pharmaceutical products on validation and risk assessment
- Provide capacity building training to staff of manufacturers on
conducting risk assessments as it relates to cleaning and other cross contamination issues
- Work with pharmaceutical manufacturers to conduct risk assessment on cross contamination
- Provide assistance to pharmaceutical manufacturers in developing and implementation of risk mitigation plans
Minimum Requirements:
- A minimum of 15 years of relevant (GMP, BE studies, GCP)
experience preferably in pharmaceutical industry under stringent regulatory
authorities (i.e. EU, US, or other ICH countries) or experience with World Health Organization's Prequalification Program
- Experience working in low- to middle-income countries
- Ability to travel internationally several times a year
Knowledge, Skills and Abilities:
* Relevant experience based on assignment applying for
* Strong knowledge and experience in dossier/CMC compilation,
validation, GMPs, GCPs, and BE protocol design and data analysis
* Attention to detail is essential
* Excellent communication and interpersonal skills
* Fluency in written and oral English required
Application Submission Requirements:
The following information must be submitted
to Sona Karia at SOK@usp.org
Clearly state the PQM technical areas of
expertise for which the applicant is applying for in the subject line of
their application e-mail.
Only applications sent to this email address will be considered.
Applications must contain the following:
Individual Applications:
1. Cover Letter with proposed rate;
2. CV/Resume; and
3. USAID Form 1420 (available at
http://www.usaid.gov/sites/default/files/AID1420-17.doc )
Business/Organizations Applications:
1. Cover Letter with proposed pricing; and
2. Proposal/outline of technical qualifications and services available
Jennifer Derry
Program Manager, Core TB, MCH and NTD
Promoting the Quality of Medicines (PQM) Program U.S. Pharmacopeial
Convention
12601 Twinbrook Parkway, Rockville, MD, 20852, USA
Jennifer Park <jpark2004@gmail.com>