The USAID Global Health Supply Chain-Quality Assurance Program (GHSC-QA) is a comprehensive QA program providing independent QA and quality control (QC) services for health commodities procured on behalf of USAID. Technical assistance (TA) is a key objective of GHSC-QA, and under this objective FHI 360 will be providing TA for the Drug and Food Quality Control Laboratory (DFQCL) in Kabul, Afghanistan.
Job Summary / Responsibilities:
The QA Manager is responsible for keeping standard operating procedures (SOPs) and work instructions (WIs) up to date and for ensuring that all personnel have received training on their required SOPs and WIs. In addition, this position maintains records documenting staff certifications for training on SOPs and WIs. The QA Manager will also be responsible for internal audits, investigations, corrective/preventive actions, and management reviews. The QA Manager is required to be a pharmacist licensed to practice in Afghanistan. The assignment is expected to be 1-2 years.
Accountabilities/Responsibilities
- Assist in the development of the quality management system (QMS).
- Review source documentation and incorporate it into the new QMS as directed by FHI 360 management.
- Work with laboratory staff to identify QMS requirements, ensuring all testing activities within the laboratory’s scope are incorporated.
- Review the QMS to ensure all policies, SOPs, appendices, and other components are correctly integrated into the QMS.
- Represent FHI 360 at meetings with USAID, the National Medicine & Health Products Regulatory Authority (NMHRA), and the DFQCL, as required.
- Perform other duties as assigned by the Quality Assurance Specialist.
Typical Physical Demands
- Typical laboratory and office tasks.
- Ability to stand and deliver presentations and facilitate meetings.
Travel Requirements
- Limited local travel from the laboratory to other locations as required to meet with stakeholders and supervisor (expected to be 30% or less).
- No international travel is expected.
Experience
- A minimum of 1 year of experience working in a relevant laboratory setting is required.
- Experience developing or working under a laboratory QMS.
Applied Skills
- Meeting logistics and facilitation: The QA Manager must be adept at planning/coordinating and leading meetings as well as speaking to large groups of stakeholders.
- QMS: The QA Manager must have a fundamental understanding of quality management, the purpose of a QMS, and how to develop and maintain one.
- Reporting: The QA Manager must be capable of providing accurate, timely reports on a daily basis in the format specified.
Additional Preferred Qualifications
- The candidate should have an interest in quality system operations.
- Experience with cloud-based computing products such as Microsoft SharePoint is desirable.
- Editing, copyediting, and/or proofreading experience are desired.
Technology Requirements:
- Proficiency in the use of Microsoft Office products including Word, Excel, PowerPoint, and Outlook.
- Use of laptop/notebook computers and smartphones.
- Training or experience in pharmaceutical analysis and QMS.
- Excellent command of written and spoken English is required.
- Good communication skills.
- Ability to work with a team.
We offer competitive compensation and an outstanding benefit package.