Since
1992, the United States Pharmacopeia has worked cooperatively with the
United States Agency for International Development (USAID) to help
developing countries address critical issues related to poor quality
medicines and their appropriate use through the Promoting the Quality of
Medicines (PQM). PQM serves as a primary mechanism to help ensure the
quality, safety, and efficacy of medicines essential to USAID priority
diseases, particularly malaria, HIV/AIDS, and tuberculosis. USP–USAID
collaborative efforts have helped communities improve drug quality in
more than 35 countries.
Supported
by knowledgeable staff and state-of-the-art facilities around the
world, PQM strives to accomplish four key objectives:
· Strengthen quality assurance (QA) and quality control (QC) systems
· Increase the supply of quality assured medicines
· Combat the availability of substandard and counterfeit medicines
· Provide technical leadership and global advocacy
USP PQM Indonesia is currently recruiting for the following position: Pharmaceutical cGMP, GCP, GLP Consultant
The
Pharmaceutical cGMP, GCP, and GLP Consultant will support the
implementation of the USP PQM work plan activities in Indonesia
providing technical assistance towards WHO Prequalification of
locally-manufactured tuberculosis and/or HIV medicines. The consultant
will provide ongoing technical support to local manufacturers on
achieving compliance with WHO requirements to submit finished
pharmaceutical product dossiers for WHO Prequalification. The
consultant must be familiar with both international cGMP standards and
WHO requirements for prequalification of medicines. The consultant will
provide high-level guidance on all aspects of product development and
CTD-format dossier submission, including stability studies, dissolution
profiling, and Bioequivalence studies as needed. The consultant will
work with local manufacturers and with local Contract Research
Organizations to support the USP PQM technical assistance program,
financed under USAID.
MAIN RESPONSIBILITIES:
· Provide
ongoing cGMP technical assistance support to local tuberculosis
medicines manufacturers under the USP PQM program in Indonesia
· Provide
ongoing GCP and GLP support to local Contract Research Organizations
for Bioequivalence studies as required for WHO prequalification
· Support CoP and USP PQM QA/QC senior management and staff to implement TB and HIV work plan activities
· Travel to provinces as needed for meetings, training, follow-up, and project implementation.
· Provide technical support to pharma manufacturers on product development and requirements.
· Other duties, as requested
REQUIRED QUALIFICATIONS:
· Master
degree or higher (PhD preferred) and minimum of 8 years of experience
in GMP, GLP, and GCP activities in the pharmaceutical industry or
regulatory environments. Preferred Apoteker licensure in Indonesia.
· Experience with WHO prequalification of medicines is a plus
· Experience
with international cGMP, GCP, GLP standards and requirements (USP, EU,
WHO, etc.) and ability to provide relevant and high-level advising to
partners in Indonesia
· Work experience in a USAID or other international donor-funded project in Indonesia desirable.
· Fluency in Bahasa Indonesia and proficiency in written and oral English required.
Interested applicants are requested to submit their CV and application to chrispqm@gmail.com by March 7, 2014 at the latest.
Only shortlisted candidates will be notified
