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 Quality Assurance/Quality Control Consultant
The
Pharmaceutical Quality Assurance/Quality Control Consultant will
support the implementation of the USP PQM work plan activities in
Indonesia related to strengthening BPOM central and provincial
laboratories, supporting post-marketing surveillance activities,
providing training support and project reporting. Activities are focused
on quality control of medicines and diagnostics products for
tuberculosis and HIV control programs in Indonesia. The consultant is
expected to provide high-level technical assistance to the Government of
Indonesia and to local manufacturers (as needed) on basic and
compendial testing based on ISO/IEC 17025, GLP requirements for WHO
Prequalification of Quality Control laboratories, ICH (The International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use), USP, and other relevant standards.
This project is financed under the USAID Indonesia mission in Jakarta,
Indonesia.
MAIN RESPONSIBILITIES:
- Provide ongoing training and technical assistance support to BPOM and other quality control laboratories in Indonesia on compendial testing under the USP PQM program.
- Coordinate activities under GFATM support, including liaising with national TB and AIDS programs, BINFAR, and BPOM
- Support CoP and USP PQM QA/QC senior management and staff to implement TB and HIV work plans including conducting sampling and testing of medicines throughout supply chain.
- Travel to central or provincial BPOM and BBPOM QC labs as needed for training, follow-up, and project implementation.
- Provide troubleshooting for equipment and systems used in compendial testing of medicines (HPLC, LC-MS MS, UV, KF titration, dissolution, etc.)
- Other duties, as requested
REQUIRED QUALIFICATIONS:
- Master degree or higher (PhD preferred) and minimum 8 years of experience in QA/QC activities in the pharmaceutical industry or regulatory environments. Preferred Apoteker licensure in Indonesia
- Expertise with at least three major analytical methods; HPLC, GC, LC-MS, GC-MS, , UV, KF titration and dissolution Experience with providing education or training on advanced compendial testing of medicines
- Experience with developing Quality Management Systems for QC laboratories, ISO/IEC 17025 requirements, SOPs, etc.
- Experience with auditing, monitoring and evaluation
- 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 February 28th 2014 at the latest.
Only shortlisted candidates will be notified
