US Pharmacopeia PQM Indonesia vacancy: Pharmaceutical cGMP, GCP, GLP Consultant

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