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).

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.