GxP审计员

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 on-going 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 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 audit plans, reports and summaries within defined timeframes and accordance with internal policies / procedures.

• Promote continual improvement regarding stakeholder satisfaction with emphasis on 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.

Required Qualifications

• Minimum bachelors degree in any scientific discipline.

• A minimum of 20 years of relevant experience including a minimum of 15 years of GxP. auditing in a regulated environment focused on quality.

• Excellent knowledge of GxP regulatory requirements.

• Experience using electronic Quality Management Systems.

• Ability to manage multiple projects in a fast-paced environment.

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

• Ability to understand when issues require escalation to Senior Quality Management.

• Must be detail oriented; must be precise and organized in handling of documents. Solid organizational skills required; must be able to prioritize multiple tasks.

Originally posted on Himalayas