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[e-drug] Local consultant for Indonesia: USP PQM Program

E-drug: Local consultant for Indonesia: USP PQM Program

Dear all

Medicines (PQM) Program

Local Consultant - Promoting the Quality of Medicines (PQM) Program - in 

Job Summary: 
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.  

Minimum Qualifications: 
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 
as necessary. 
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. 

Starting date: 
January 2011 

Further enquiries: 
Contact Dr. Souly Phanouvong at pqm@usp.orgTel. +1 301 816 8582; Fax: +1 301 
816 8374
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