E-drug: Local consultant for Indonesia: USP PQM Program
JOB DESCRIPTION - A LOCAL CONSULTANT �INDONESIA� USP Promoting the Quality of
Medicines (PQM) Program
Local Consultant - Promoting the Quality of Medicines (PQM) Program - in
Coordinate PQM activities to support the manufacturers of tuberculosis (TB)
medicines toward the World Health Organization Pre-qualification (WHO PQ)
Scheme and other PQM-support project activities to strengthen the quality
assurance and quality control of medicines in Indonesia. The incumbent will
also provide technical advice to TB manufacturers and other project partners,
follow up on PQM activities on a regular basis and report to PQM HQ.
PharmD in Pharmaceutical Sciences or Master degree in Chemistry, Ph.D
preferred. Extensive knowledge and experience in regulatory affairs in
pharmaceuticals and common technical documents in line with national and
international requirements. At least five years experience in pharmaceutical
manufacturing, quality assurance and control, including GMP inspections for
regulatory compliance, preparation of dossier for product registration, or
quality management environment. Good knowledge of GMP/GLP and its applications
in various lab settings. Experience in working with National Agency for Drugs
and Food Control (NADF), international non-governmental organizations and
national diseases programs strongly preferred. Experience with USAID and/or WHO
a plus. Strong communication skills in English and Bahasa required. Ability to
travel within the country.
Major Duties & Responsibilities:
1. Works closely with current USP PQM Program Manager/Specialists under the
guidance of the Manager for Asia to provide technical assistance to partners in
Indonesia, specifically to the TB manufacturers to obtain WHO PQ.
2. Develops relationships with USAID missions and other partners in the country.
3. Provides new ideas and technically sound guidance to develop, implement,
monitor and evaluate work plan activities.
4. Represents USP PQM as required in scientific and technical meetings in the
5. Participates in sessions on medicines quality assurance at regional and
national technical meetings, as necessary.
6. Provides inputs to the development of work plans and prepares reports as
7. Coordinates other USP PQM-supported activities in the country such as the
medicines quality monitoring and strengthening capacity of the NADF.
8. Prepare and report updates and progress to PQM HQ in a regular basis and/or
9. Performs other related duties, as assigned.
Principal Working Relationships:
USP: PQM staff and consultants; International Affairs Group
USAID, WHO, NADF and QC labs in Indonesia and the region.
Contact Dr. Souly Phanouvong at email@example.comTel. +1 301 816 8582; Fax: +1 301