Senior IT Quality Compliance Specialist | Pharma | Geel
Core
Ensure IT systems, processes, and methodologies remain compliant with GMP guidelines and quality requirements in a pharmaceutical environment.
Role type
Senior IT Quality Compliance Specialist
Builds
Audit-ready, efficient, and future-oriented quality environments
Domain
Pharmaceutical industry + IT Quality/Compliance
Required skills
GxP compliance, CAPA management, change control, deviation management, audit support, gap assessment, process optimization, CSV knowledge, QA expertise
Preferred skills
None stated
Technologies
GAMP 5, 21 CFR Part 11, EU Annex 11
Responsibilities
Manage and follow up on periodic quality activities and reviews, Coordinate CAPAs, change controls, and deviation processes, Support internal and external audits and inspections, Review and approve quality documentation and procedures, Identify and implement process improvements within IT Quality, Execute gap assessments and correct compliance deviations, Lead improvement projects and sporadic CSV initiatives
Seniority
Senior, hands-on IC