POSITION: Pharmaceutical QA/QC Specialist
DUTY STATION: Jakarta, Indonesia with travel in Indonesia
REPORTS TO: Indonesia Chief of Party
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.
- 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.
- 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
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