Gxp Auditor

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8gdg3h

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-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8gdg3h