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 NOTE: All applicants must currently reside in Indonesia with valid kitas/work permit or local KTP

Job Email id:

chrispqm(at)gmail.com