Job Title: Quality Assurance Auditors (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 Quality Assurance Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with current Good Manufacturing Practices (cGMP), international regulatory requirements and the company’s Quality Management System (QMS).
The role supports audit readiness, identifies gaps in systems and operations, monitors implementation of corrective and preventive actions (CAPAs) and ensures continuous quality improvement. QA Auditors will work across departments to evaluate quality risks, assess documentation compliance and support third-party inspections or regulatory audits (e.g., NDA, WHO, FDA). The ideal candidate must demonstrate deep knowledge of pharmaceutical quality systems, audit procedures, and regulatory standards, with excellent communication and analytical skills.
Key Duties and Responsibilities:
- Develop annual internal audit schedules and conduct audits in accordance with approved plans and SOPs.
- Evaluate the effectiveness of GMP compliance across production, quality control, warehousing, and engineering departments.
- Prepare detailed audit reports, identify observations, and follow up on implementation of CAPAs.
- Participate in vendor qualification and conduct external audits of raw material and packaging suppliers.
- Assess the suitability and effectiveness of QMS elements including deviations, change controls, CAPAs, and documentation practices.
- Support audit readiness for regulatory inspections and client audits.
- Conduct gap assessments against ICH, WHO, NDA Uganda, US FDA and other applicable regulatory frameworks.
- Train staff on audit findings, regulatory requirements, and quality system improvement initiatives.
- Monitor compliance trends and support risk-based decision making in quality-related matters.
- Maintain strict confidentiality and independence in audit execution and reporting.
Qualifications, Skills and Experience:
- Bachelor’s degree in Pharmacy, Industrial Chemistry, Quality Management, or a related scientific field. Postgraduate certification in Quality Systems or Auditing (e.g., ISO 9001 Lead Auditor) is an added advantage.
Experience and Competencies:
- Minimum of 4–5 years’ experience in pharmaceutical quality assurance, with at least 2 years in audit or compliance roles.
- Proven experience conducting internal and supplier audits in a GMP regulated environment.
- Strong understanding of international quality guidelines and regulatory expectations (e.g., WHO GMP, ICH Q10, ISO 9001).
- Excellent report writing, analytical, and presentation skills.
- Proficient in audit tools, risk assessment, and quality system monitoring.
- High integrity, objectivity, and ability to work across multidisciplinary teams.
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 recruitment@deibiopharma.com 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