QA Auditor

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 ensures 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, and Study Plans, ensuring full compliance.
• Participate in the maintenance of the quality system.
• Forecast, monitor, and control the work volume within QAU and plan/organise all activities accordingly.
• Schedule and perform:
  • Study audits
  • Facility audits
  • Process audits in compliance with SOPs.
• Communicate audit outcomes to relevant personnel and site management, ensuring appropriate audit responses are implemented.
• Maintain the CAPA system and follow up on CAPA actions to completion.
• Prepare and sign QA statements for inclusion in reports in accordance with SOPs.
• Submit audit reports for archiving—the applicable SOP must be followed.
• Approve GMP documentation (where applicable).
• Participate in computerized system validation teams (as required).
• Review Standard Operating Procedures (SOPs) for consistency, compliance, and accuracy; maintain QA SOPs as a core responsibility.
• Manage and conduct assessments of key company suppliers as requested by management, ensuring compliance with regulatory guidelines.
• Provide guidance, training, and consultation on quality-related issues.
• Support the QA Manager in managing and hosting sponsor and monitoring authority inspections.
• Adhere to:
  • Appropriate regulatory guidelines
  • SOPs
  • Policies
  • Study documentation
• Work in full compliance with standard operating procedures (SOPs) by:
  • Authoring
  • Reviewing
  • Maintaining SOPs, guidance documents, and policies
  • Providing training and support to staff