Role Overview

The QA Auditor plays a key role in maintaining quality and regulatory compliance across the organisation. Responsible for conducting audits, managing CAPAs, reviewing quality documentation, and supporting inspections, the role helps ensure adherence to regulatory requirements, SOPs, and industry standards while driving continuous improvement and quality excellence.

Key Responsibilities

• Follow and where applicable implement appropriate laws, regulatory guidelines, SOPs, Study Plans.
• Participating in the maintenance of the quality system.
• Forecast, monitor and control the work volume within QAU.
• Plan and organise all activities within the QAU.
• Schedule and perform study, facility and process audits in compliance with SOPs.
• Communicate the audit outcome to relevant personnel and site management and ensure that audit responses are appropriate.
• To maintain the CAPA system and follow up CAPA actions.
• Prepare and sign QA statements for inclusion in reports in accordance with SOPs.
• Submit audit reports for archiving in accordance with the applicable SOP.
• To approve GMP documentation where applicable.
• To participate in computerized system validation team where applicable.
• Review Standard Operating Procedures for consistency and compliance and maintaining QA SOPs.
• Manage and conduct assessment of key company suppliers as requested by management to ensure compliance with regulatory guidelines.
• Provide guidance, training and consultation in quality-related issues.
• Support QA Manager in management and hosting of sponsor and monitoring authority inspections.
• Observe appropriate regulatory guidelines, SOPs, policies and study documentation.
• Working in accordance with standard operating procedures (SOPs) by authoring, reviewing, and maintaining SOPs, guidance documents, and policies, as well as providing training and support to staff.