Job Title: Production Officer – Medical Diagnostic Devices (4 Jobs)
Organisation: Dei BioPharma Ltd
Duty Station: Matugga, Wakiso, Uganda
About the Company:
Dei BioPharma Ltd is a biotech and pharmaceutical research firm duly incorporated in Uganda, specializing in the development and manufacture of innovative medicines and vaccines. Our state-of-the-art manufacturing facility, situated in Matugga, Wakiso district, Uganda, shall produce high-quality medicines across a wide range of therapeutic areas.
Job Summary: The Production Officer – Medical Diagnostic Devices is responsible for the planning, supervision, and execution of manufacturing operations for in vitro diagnostic (IVD) kits, lateral flow devices, and other medical diagnostics. The role entails oversight of formulation, reagent dispensing, membrane coating, assembly, labeling and packaging processes in compliance with ISO 13485, current Good Manufacturing Practices (cGMP) and local regulatory requirements. The officer will manage production personnel, ensure batch traceability and collaborate with quality assurance, R&D and maintenance teams to deliver high-quality, regulatory-compliant diagnostic products. The ideal candidate must demonstrate technical expertise in diagnostics manufacturing and a strong understanding of cleanroom and sterility requirements for medical device production.
Key Duties and Responsibilities:
- Plan, organize and supervise day-to-day production activities of diagnostic devices in accordance with batch production records and SOPs.
- Oversee raw material preparation, reagent formulation and semiautomated/automated production processes such as dispensing, laminating, die-cutting, and assembly.
- Monitor critical process parameters and environmental conditions in cleanroom and controlled zones.
- Ensure adherence to ISO 13485, GMP and internal quality management system (QMS) during all manufacturing activities.
- Maintain accurate production documentation, equipment logs, and material traceability records.
- Train and manage production staff to uphold compliance, productivity and safety standards.
- Participate in validation, scale-up and troubleshooting of production processes and new device formats.
- Support internal and external audits by ensuring documentation and operational readiness.
- Coordinate preventive maintenance and calibration of equipment with engineering and QA teams.
- Drive continuous improvement initiatives to enhance efficiency, reduce waste and improve quality.
Qualifications, Skills and Experience:
- Bachelor’s degree in Biomedical Engineering, Industrial Chemistry, Biotechnology, Medical Laboratory Sciences or a related field.
- Certification or training in ISO 13485 and GMP is an added advantage.
Experience and Competencies:
- Minimum of 3–5 years’ experience in medical diagnostics or medical device manufacturing.
- Hands-on experience in the production of lateral flow devices, ELISA kits, or other IVD technologies.
- Sound knowledge of cleanroom operations, device assembly workflows, and aseptic handling.
- Familiarity with ISO 13485:2016, cGMP, and QMS documentation requirements.
- Demonstrated ability to supervise production teams and work in a regulated manufacturing environment.
- Strong problem-solving, documentation, and cross-functional coordination skills.
How to Apply:
All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Human Resources Manager)
All Application documents should be merged as one document in PDF or .DOC / .DOCX, which should not exceed 10MB
Applications should be sent by email to [email protected] with the JOB TITLE IN THE SUBJECT LINE.
Should you not hear from us within twenty-one (21) days from the closing date of this advertisement, you may consider your application to be unsuccessful.
Deadline: 12th May 2025 by 5:00 PM
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