Gxp Auditor

GxP Auditor is responsible for planning and conducting scheduled quality audits, acting as a Subject Matter Expert for GxP auditing and quality projects, 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.
• Perform audits across various departments and functional areas.
• 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.
• Collaborate with cross-functional teams to ensure audit findings are addressed and resolved.
• 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.
• Produce draft and final versions of audit plans, reports, and summaries within defined timeframes and in accordance with internal policies/procedures.
• Promote continual improvement regarding stakeholder satisfaction, emphasizing Quality/GxP auditing services.
• Stay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge.