Quality Assurance Auditors (Number of positions: 04)

Announcement Number: DB/05/2025/QA01
Position Title: Quality Assurance Auditors (Number of positions: 04)
Opening Period: 05/05/2025 – 05/12/2025
Series/Grade: L (4)
Salary: Competitive
Who May Apply: All Interested Applicants
Duration Appointment: Indefinite, subject to successful completion of probationary period
Supervisory Position: None

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:

1. Develop annual internal audit schedules and conduct audits in accordance with approved plans and SOPs.
2. Evaluate the effectiveness of GMP compliance across production, quality control, warehousing, and engineering departments.
3. Prepare detailed audit reports, identify observations, and follow up on implementation of CAPAs.
4. Participate in vendor qualification and conduct external audits of raw material and packaging suppliers.
5. Assess the suitability and effectiveness of QMS elements including deviations, change controls, CAPAs, and documentation practices.
6. Support audit readiness for regulatory inspections and client audits.
7. Conduct gap assessments against ICH, WHO, NDA Uganda, US FDA and other applicable regulatory frameworks.
8. Train staff on audit findings, regulatory requirements, and quality system improvement initiatives.
9. Monitor compliance trends and support risk-based decision making in quality-related matters.
10. Maintain strict confidentiality and independence in audit execution and reporting.

Academic Qualifications:
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:

1. Minimum of 4–5 years’ experience in pharmaceutical quality assurance, with at least 2 years in audit or compliance roles.
2. Proven experience conducting internal and supplier audits in a GMP-regulated environment.
3. Strong understanding of international quality guidelines and regulatory expectations (e.g., WHO GMP, ICH Q10, ISO 9001).
4. Excellent report writing, analytical, and presentation skills.
5. Proficient in audit tools, risk assessment, and quality system monitoring.
6. High integrity, objectivity, and ability to work across multidisciplinary teams.