E-drug: Local consultant for Indonesia: USP PQM Program
-------------------------------------------------------
Dear all
JOB DESCRIPTION - A LOCAL CONSULTANT “INDONESIA“ USP Promoting the Quality of Medicines (PQM) Program
Position:
Local Consultant - Promoting the Quality of Medicines (PQM) Program - in Indonesia
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 country.
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 necessary.
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