COMPUTER SYSTEM VALIDATION & DATA INTEGRITY CONSULTANT - AMBITO GCP
Core
Managing Computer System Validation (CSV) activities and Data Integrity requirements for GCP-compliant systems in the regulatory consulting sector.
Role type
Computer System Validation & Data Integrity Consultant
Builds
Validation documentation (Plans, Risk Assessments, Protocols, Reports) and compliant computerized systems for pharma clients
Domain
Pharmaceutical industry + Regulatory Compliance (GxP/GCP)
Required skills
Computer System Validation (CSV), Data Integrity, GCP requirements, GxP processes, Technical validation documentation, Gap analysis, Corrective action planning
Preferred skills
Internal/external audit coordination, Regulatory inspection support, Client strategy definition
Technologies
GCP, GMP, GxP
Responsibilities
Manage CSV activities, Evaluate and apply Data Integrity requirements, Write GMP/GCP documentation, Support clients in validation strategies, Execute internal/external compliance audits, Analyze compliance gaps, Support regulatory inspections
Seniority
Mid-level, hands-on IC