Quality Assurance Specialist at Mission for Essential Drugs and Supplies (MEDS)

Key Responsibilities:

1. Coordinate and conduct prequalification of vendors, suppliers, manufacturers and products.
2. Responsible for technical activities during storage and distribution including installation of temperature and relative humidity control and monitoring systems for warehouses and vehicles, continuous monitoring and maintenance of records.
3. Coordinate sampling and testing of health commodities including pre- and post-procurement sampling and testing, post marketing surveillance sampling and testing, maintaining certificates of analysis and preparing activity reports.
4. Sample and inspect commodities delivered by suppliers for compliance with set specifications.
5. Manage internal and external audits, regulatory agency inspections, and product recalls.
6. Customize procedures for the project and coordinate in-house GDP staff trainings.
7. Coordinate pharmacovigilance activities in line with current PPB guidelines.
8. Investigate and resolve quality-related complaints.
9. Maintain current knowledge of relevant GoK, USG regulations and ensure compliance.
10. Responsible for regulatory affairs activity for the project including processing import permits and waivers and maintaining necessary records.
11. Conduct temperature mapping and validation for new storage areas, systems and equipment including preparation and execution of protocols, preparation of validation reports and commissioning the systems for use.
12. Manage quality events during procurement, storage and distribution of commodities
13. Coordinate equipment calibration and maintenance schedule
14. Participate in Technical Evaluation Committee
15. Ensure material handling tools such as forklifts, pallet movers etc. are operational for efficient use
16. Manage packaging materials and related consumables for efficient use.
17. Implement occupational safety guidelines in the warehouse for compliance with government authorities

Candidate Profile:

1. At least 3 years’ experience from GMP facility and knowledge of GMP and GDP Standards
2. Bachelor’s Degree in Pharmacy and Registered with Pharmacy and Poisons Board.