GxP Auditor

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