01 ago - Italia
RxCloud
Gx P Auditor is an integral member of the Quality and Compliance team. The Gx P Auditor is responsible for planning and conducting scheduled quality audits on behalf of Rx Cloud . This position will also act as a Subject Matter Expert (SME) for Gx P auditing and quality projects and will be responsible for supporting the ongoing development and management of the Quality Management Auditing system. This position is responsible for independently managing quality/Gx P auditing deliverables scheduled. Responsibilities Include Function as a Quality/Gx P 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, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved. 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. Responsible for leading, conducting, and documenting investigations relating to audit findings noted internally. Utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings. 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
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