Posted Sep 24, 2016 20 views
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.
Summary of the Position:
Working under the direction and guidance of the Senior Program Consultant of the USP Promoting the Quality of Medicines (PQM)-Pakistan, he/she will be responsible for providing technical assistance in Good Manufacturing Practices (GMP) to support the USP/PQM program development and effective implementation to meet its set goals and objectives. The GMP Specialist will provide technical assistance for full compliance to national GMP standards and moving towards WHO Prequalification of locally-manufactured maternal and child health (MCH) and other essential pharmaceutical products. The GMP Specialist will provide high-level guidance on all aspects of product development and common technical document format dossier submission, including stability studies, dissolution profiling, and bioequivalence studies, as needed. In addition, the GMP Specialist will work with local manufacturers and with local Contract Research Organizations to support the USP PQM technical assistance program, financed under USAID.
Roles and Responsibilities:
Provides ongoing GMP technical assistance support to local manufacturers of MCH and other medicine manufacturers under the USP PQM technical assistance program in Pakistan
Supports the Senior Program Consultant and staff involved in USP PQM quality assurance and quality control activities in implementing MCH work plan activities
Provides technical support to pharmaceutical manufacturers on product development and requirements
Provides ongoing cGMP technical assistance to local manufacturers producing chlorhexidine gel toward successful production of commercial batches to support the scale up of CHX project.
Provides technical support to local manufacturers on achieving compliance with WHO requirements to submit finished pharmaceutical product dossiers for WHO Prequalification status.
Travels to provinces as needed for meetings, training, follow-up, and project implementation.
Supports DRAP GMP Inspector when attending national, regional or international training
Performs other duties as requested
Minimum Requirements
Education and Experience:
Education
- Bachelor’s degree in chemistry, pharmacy, or related field; a higher degree will be an advantage
Experience:
At least five years’ experience in GMP in the pharmaceutical industry or regulatory environments
Experience in the establishing compliance with quality systems within pharmaceutical manufacturing companies
Knowledge, Skills and Abilities (KSA’s):
In-depth knowledge on WHO GMP standards/guidelines and WHO Prequalification of Medicines Programme will be considered a plus
Familiarity with both international current GMP standards and WHO requirements for the prequalification of medicines.
Knowledge of and experience with the WHO Prequalification of Medicines Program will be considered a plus
Experience working within a cGMP regulated Quality control laboratory is also a plus
Ability to work independently and to liaise and coordinate activities between different agencies that USP/PQM works with.
Excellent communication skills (written and oral): sensitivity to and responsiveness to all partners, donors and program staff.
Excellent analytical skills; mature judgment combined with a proactive, energetic approach to problem solving.
Proficient in English language (written and spoken).
Ability to travel as necessary.
Job Details
US Pharmacopeia
US Pharmacopeia
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