Scope of Work
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
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Scope of Work
POSITION: Communications and Monitoring & Evaluation Specialist
REPORTS TO: Senior Project Coordinator
DUTY STATION: Jakarta, Indonesia with travel in Indonesia
OVERVIEW:
The Communications and Monitoring & Evaluation (M&E) Specialist will provide high-level support for the implementation of the United States Pharmacopeia’s Promoting the Quality of Medicines Indonesia work plan activities related to strengthening quality assurance and quality control of HIV, TB, and other essential medicines. The Communications and M&E Specialist will work primarily with BPOM, the Ministry of Health (National TB and HIV/AIDS Control Programs (P2PL) and BINFAR), and Indonesian TB and ARV medicines manufacturers, the Global Fund, and other partners to help with the establishment of a national quality assurance program for anti-tuberculosis, antiretrovirals, OI, STI, and other essential medicines throughout the supply and distribution chains.
As part of the USP PQM Indonesia country team, the Communications and M&E Specialist will be responsible for developing and maintaining various communications media on behalf of the program, as well as initiating activity-based public awareness and advocacy campaigns in collaboration with the Government of Indonesia and with selected private sector stakeholders. The Communications and M&E Specialist will also be responsible for developing routine communications materials for distribution to partners and donors.
In addition, the Communications and M&E Specialist will assist Senior Project Coordinator in collecting, processing and analyzing data in relation to the Monitoring and Evaluation frameworks and reporting on program indicators for the PQM Indonesia office.
The Communications and M&E Specialist is expected to maintain effective communications with program country and international partners, especially with USP headquarters and the USAID Indonesia Mission. This project is financed under the US Agency for International Development Indonesia Mission.
MAIN RESPONSIBILITIES:
· Takes the lead in the co-development of USP PQM’s Communications and Advocacy Plan, including key audiences, key messages, channels, and USP PQM Indonesia’s ‘brand’
· Initiates activity-based public awareness and advocacy materials in line with approved HIV and TB work plans in collaboration with Government of Indonesia and private sector stakeholders
· Develops effective communications strategy for the PQM Indonesia field office, including routine communications (website, newsletters, social media, etc.) as needed for distribution to donors and partners
· Contributes to quarterly and annual reports for the PQM Indonesia field office
· Provides inputs into collaborative communications strategies between BPOM and the Ministry of Health as outlined in approved work plans
· Assists the Senior Project Coordinator in the collection and interpretation of data for reporting on program indicators for the Indonesia field office, and contribution to overall knowledge management of the PQM program
· Travels to central or provincial sites as needed
· Supports the CoP and other program staff to establish the work plan implementation 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
REQUIRED QUALIFICATIONS:
· S1-level undergraduate university degree in communications, social sciences, or public health with a health communications focus
· High proficiency in English, both oral and written, as evidenced by submission of IELTS or TOEFL scores taken between 2014 to 2016
· 3 years’ experience working on development of public or government communications programs, health-related public awareness and/or advocacy projects within Indonesia or internationally
· Demonstrated knowledge of and experience in monitoring and evaluating programs, including indicator development, study design, and data analysis in public health sector
· Experience working with Government of Indonesia partners, international donors and/or NGOs would be an advantage
· Fluency in Bahasa Indonesia
· Highly developed computer skills
Please submit current CV and evidence of salary history (AID1420 form available athttp://www.usaid.gov/sites/
With copy to: usppqm.indonesia@gmail.com
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