Computerized Systems Validation Specialist
Core
Ensuring all IT systems impacting Good Manufacturing Practices are in a validated state and maintaining compliance with international regulations.
Role type
Computerized Systems Validation (CSV) Specialist
Builds
Validated IT systems and software/hardware configurations for pharmaceutical packaging operations
Domain
Pharmaceutical industry / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CSV setup and execution, GAMP 5 knowledge, GMP guidelines, quality systems, risk assessment, test protocol development, validation documentation, audit support
Preferred skills
Experience with validation studies, analytical thinking, ability to work independently and in teams
Technologies
GAMP 5, GMP-compliant systems
Responsibilities
Develop detailed test protocols, document validation activities and results, support internal and external audits, ensure compliance with international regulations, maintain overview of IT systems and validation status
Seniority
Mid-level, hands-on IC