POSITION:
Pharmaceutical QA/QC Specialist DUTY
STATION: Jakarta, Indonesia with travel in Indonesia REPORTS
TO: Indonesia Chief of Party            OVERVIEW:The Pharmaceutical Quality Assurance/Quality
Control Specialist 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 Technical Advisor 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 Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use), USP, and other relevant
standards. This project is funded under the USAID Indonesia mission Office of
Health in Jakarta, Indonesia.MAIN RESPONSIBILITIES:·        
Provide ongoing training and
technical assistance support to BPOM and other quality control laboratories in

Indonesia on basic and compendial testing under the USP PQM program.·        
Provide
assistance to BPOM staff at National and Provincial Lab on drafting and review
and implementation of their SOP or written procedures.·        
Provide
assistance and support BPOM staff at National and Provincial Lab on
implementation of Quality Management System·        
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.).·        
Conduct
pre-assessment and support the USP Expert on assessment in provincial lab.·        
Coordinates
activities for visiting USP experts, consultants, and scientists·        
Supports
Logistic and Procurement Officer on procurement activities·        
Support and

follow up Corrective and Preventive Action reports of assessment to improve the capabilities of
provincial QC Lab·        
May be expected to provide
inputs into GMP-related activities·        
Support CoP
establish the work plan implementation and report annually·        
Prepares documents and reports
in English and Bahasa for submission to supervisor, partners and donors·        
Works effectively as a member
of a small country office team·        
Performs
other duties as assigned  MINIMUM
REQUIRED QUALIFICATIONS: ·        
S1-level Bachelor degree in Pharmacy, Chemistry, or related field with
3 years’ experience or in Quality Control activities in the pharmaceutical
industry or regulatory environments.  Required Experience:·        
S1-level Bachelor degree in Chemistry, Pharmaceutical Sciences or related field with 3years’
experience or Master’s degree with 2 years’ experience in QC activities in the

pharmaceutical industry. ·        
2 to 3 years’ experience
working in a pharmaceutical QC laboratory·        
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 such as HPLC,
GC and dissolution.·        
Experience with validation and
verification test method according to compendial standard.·        
Experience with developing
Quality Management Systems for QC laboratories, ISO/IEC 17025 requirements,
SOPs, Quality Manual, etc.·        
Experience with auditing,
monitoring and evaluation·        
Work experience in a USAID or
other international donor-funded project in Indonesia is preferred·        
Effective communication skills
as a team player, and experience with project implementation at national and
local levels·        
Fluency in Bahasa Indonesia and
proficiency in written and oral English required   Please
submit current CV and evidence of salary history (AID1420 form available at http://www.usaid.gov/sites/default/files/AID1420-17.doc)
to: USPindonesia@usp.org