Senior CSV Quality Assurance Specialist (f/m/d)
Core
Lead risk-based Computerized System Validation (CSV) and Data Integrity (DI) for GMP processes, ensuring inspection readiness and compliance with cGMP regulations.
Role type
Senior CSV Quality Assurance Specialist (Regulated Environment)
Builds
Validated computerized systems, data integrity frameworks, and quality management processes for manufacturing, packaging, and laboratory operations.
Domain
Biopharmaceutical / Life Sciences / GxP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computerized System Validation (CSV), Data Integrity (DI), GMP Compliance, Risk-Based Approach, Change Control, Deviation Management, CAPA, Master Data Management, Inspection Readiness, Regulatory Knowledge (FDA/EU/ICH/GAMP5)
Preferred skills
Laboratory instrumentation experience, Project Management, Strategic Leadership
Technologies
GAMP5, 21 CFR Part 11, Annex 11, Annex 22, CSA
Responsibilities
Lead risk-based CSV and validate systems to ensure inspection readiness; Provide expert Data Integrity (DI) guidance and oversight; Drive standardization across the GMP environment for computerized systems and data integrity; Resolve regulatory non-conformances for cGMP systems; Develop and maintain training on validation and data integrity; Represent DDQ in global governance meetings.
Seniority
Senior, hands-on IC with strategic lead responsibilities