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IT Compliance Engineer
On-site in Cork·Full-time·Added 6 days ago (last checked 21 Oct)
Our summary
- Work mode
- On-site, Cork
- Contract
- Full-time
Skills
The role
IT Compliance Engineer - The IT Compliance Engineer ensures that IT infrastructure applications and data systems in a life science manufacturing environment meet GxP 21 CFR Part 11 EU Annex 11 and data integrity requirements. The role supports qualification validation and lifecycle control of systems manages audit readiness and partners with IT QA and Operations to maintain a secure compliant and inspection-ready state.
What you'll do
- Perform infrastructure qualification (servers networks virtualization cloud) and support CSV activities per GAMP 5 for GxP applications
- Ensure IT systems comply with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) principles
- Develop review and maintain IT SOPs policies and validation documentation covering backup security access management and disaster recovery
- Manage change control deviations CAPAs and impact assessments for IT systems to maintain a validated state
- Conduct periodic reviews access reviews audit trail reviews and system risk assessments
- Support internal audits customer audits and regulatory inspections including preparing evidence and responding to findings
- Evaluate and qualify vendors cloud providers and service partners for GxP suitability and quality agreements
- Partner with Cybersecurity to align IT controls with compliance requirements (e.g. user access patching vulnerability management OT/IT segmentation)
- Monitor compliance metrics identify gaps and drive remediation and continuous improvement initiatives
- Provide compliance guidance and training to IT teams system owners and project teams on GxP and data integrity expectations
About Cognizant
Cognizant is a global IT services and consulting company whose engineers, consultants, researchers and innovators turn ideas into AI and advanced technologies for client organizations. It serves a wide range of industries including automotive, banking, consumer goods, communications and media, healthcare, insurance, retail, manufacturing, and travel and hospitality.
Its work spans areas such as data and AI, digital engineering, business processes, and consulting, helping leading organizations convert ideas into action. The company describes a supportive culture focused on continuous learning and career growth.
- Industry
- IT Services
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