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IT Audit Expert
3 weeks ago
Role Overview:
This role ensures effective coordination and management of audits involving systems and processes. It involves supporting regulatory inspections by authorities such as FDA, EMA, MHRA, and Swissmedic.
Key Responsibilities:
- Manage audit processes across systems, focusing on quality, and regulatory-related audits, along with stakeholder engagement, remediation tracking, status reporting, and lessons-learned sharing.
- Coordinate audit activities, ensuring effective communication, and maintaining compliance throughout the process.
- Notify and mobilize relevant stakeholders for audits and inspections, ensuring timely readiness.
- Conduct pre-audit meetings to clarify scope, agree on auditor requirements, align timelines, and ensure stakeholders understand expectations for audits and inspections.
Requirements:
- University degree or equivalent in IT, Quality Management, Business Administration, or related fields.
- Overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization.
- Experience in regulated industries, with knowledge of GxP processes and compliance requirements.
