Consultant Life Science IT Compliance / CSV (w|m|d)
Core
Develop and implement strategies and concepts for Life Science companies (Pharma and Chemical) focusing on Computer System Validation (CSV) and IT Compliance.
Role type
Senior IT Compliance Consultant (CSV)
Builds
IT Compliance strategies, validation concepts, and process optimization frameworks for regulated environments.
Domain
Life Science (Pharma/Chemical) / IT Compliance / Regulatory Affairs
Required skills
Computer System Validation (CSV), IT Compliance, Regulatory Requirements (FDA, GxP, EU GMP Annex 11), Project Management, Requirements Analysis, Process Optimization
Preferred skills
Experience with lab or production IT systems, Academic degree (MSc/PhD) in technical or natural sciences
Technologies
ERP, DMS, LIM systems
Responsibilities
Advise management and IT departments on IT Compliance; Lead and participate in CSV projects; Support tendering processes; Assist customers in implementing new IT Compliance requirements; Accompany IT Compliance audits; Capture requirements for ERP, DMS, and LIM systems; Create training materials and facilitate workshops.
Seniority
Senior, hands-on IC