Quality Assurance Manager (m/w/d) Computersystemvalidierung (CSV)
Core
Planning, coordinating, and implementing validation of computerized systems in compliance with regulations; ensuring legal compliance throughout the validation lifecycle.
Role type
Quality Assurance Manager (CSV)
Builds
Validated computerized systems for pharmaceutical manufacturing
Domain
Pharmaceutical industry + Computer System Validation (CSV)
Required skills
Computer System Validation (CSV), GAMP5, GMP compliance, Risk Management, Document Management, Data and System Security, Periodic Reviews, CAPA handling
Preferred skills
Life-cycle management of computerized systems
Technologies
GAMP5, GMP
Responsibilities
Plan, coordinate, and implement validation of computerized systems; Manage all documentation generated during validation projects; Conduct risk management in the context of CSV; Ensure data and system security; Act as the first point of contact for validation-related questions; Plan, supervise, and monitor validation and qualification measures; Coordinate and process deviations, changes, and CAPAs; Create and review GMP-related documents.
Seniority
Senior, hands-on IC