GxP Auditor

GxP Auditor is an integral member of the Quality and Compliance team. Responsible for planning and conducting scheduled quality audits and supporting the development and management of the Quality Management Auditing system.

Requirements

• Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.
• Develop and implement the global audit strategy, aligning with organizational goals and regulatory requirements.
• Conduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures.
• Review and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes.
• Conduct investigations into allegations of fraud, unethical practices, or non-compliance, and recommend appropriate actions to address such issues.
• Prepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders.
• Lead, conduct, and document investigations relating to audit findings noted internally.
• Ensure audits are performed within budget and according to plan.
• Facilitate post-audit debriefs with internal stakeholders within defined timeframes ensuring clear communication of audit findings.
• Produce draft and final versions of audit plans, reports and summaries within defined timeframes and accordance with internal policies / procedures.
• Promote continual improvement regarding stakeholder satisfaction with emphasis on Quality/GxP auditing services.