Gxp Auditor
Pubblicato il 23-10-2026 - RxCloud in Italia
ppbGxP Auditor /bis an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of bRxCloud. /b This position will also act as ab Subject Matter Expert /b(SME) for bGxP auditing /band 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. /p h3Responsibilities Include /h3 ul liFunction as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations. /li liDevelop and implement the global audit strategy, aligning with organizational goals and regulatory requirements. /li liPerform audits across various departments and functional areas. /li liConduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures. /li liReview and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes. /li liCollaborate with cross-functional teams, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved. /li liConduct investigations into allegations of fraud, unethical practices, or non-compliance, and recommend appropriate actions to address such issues. /li liPrepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders. /li liResponsible for leading, conducting, and documenting investigations relating to audit findings noted internally.
/li liUtilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings. /li liEnsure audits are performed within budget and according to plan. /li liFacilitate post-audit debriefs with internal stakeholders within defined timeframes ensuring clear communication of audit findings. /li liProduce draft and final versions of audit plans, reports, and summaries within defined timeframes and by internal policies/procedures. /li liPromote continual improvement regarding stakeholder satisfaction with emphasis on Quality/GxP auditing services. /li liStay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge. /li /ul h3Required Qualifications /h3 ul liMinimum bachelors degree in any scientific discipline. /li liA minimum of b20 years /bof relevant experience including a minimum of b15 years /b of GxP. auditing in a regulated environment focused on quality. /li liExcellent knowledge of GxP regulatory requirements. /li liExperience using electronic Quality Management Systems. /li liAbility to manage multiple projects in a fast-paced environment. /li liAbility to collaborate effectively in a dynamic, cross-functional matrix environment. /li liAbility to understand when issues require escalation to Senior Quality Management. /li liMust be detail oriented; must be precise and organized in the handling of documents. Solid organizational skills are required; must be able to prioritize multiple tasks. /li /ul /p #J-18808-Ljbffr