JobMesh

Gxp Auditor

RxCloud · Rome, Lazio, IT

GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on...

Job description

GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of RxCloud. This position will also act as a Subject Matter Expert (SME) for GxP 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/GxP auditing deliverables scheduled. Responsibilities Include: · 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, including finance, operations, compliance, and legal, to ensure audit finding...