IT Compliance Specialist (m/w/d)
Core
Implement and monitor regulatory requirements for IT systems in a regulated environment, ensuring compliance with GxP standards and managing IT infrastructure qualification.
Role type
IT Compliance Specialist (regulated industry)
Builds
Compliant IT systems and processes for pharma/biotech operations
Domain
Life Sciences / Pharma / Regulatory Compliance
Required skills
GxP requirements knowledge, EU-GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, CSV/CSA, Data Integrity (ALCOA+), IT infrastructure qualification, Cloud service compliance assessment, Change management, Supplier audit support, Internal/external audit preparation, Training delivery
Preferred skills
Risk-based thinking, Structured independent work style, Consulting and service orientation
Technologies
IT infrastructure, Cloud platforms, IT Service Management tools