Senior QA Expert CSV & Data Integrity 60-80%
Core
Lead Data Integrity (DI) assessments and Computerized System Validation (CSV) for manufacturing and laboratory systems to ensure compliance and quality in drug product manufacturing.
Role type
Senior QA Expert (Data Integrity & CSV)
Builds
Compliant, qualified, and inspection-ready computerized systems (MES, BMS, production/lab equipment) and robust data integrity practices.
Domain
Pharmaceutical manufacturing / GMP-regulated environment
Required skills
GMP compliance, Computerized System Validation (CSV), Data Integrity, deviation handling, change management, quality risk assessment, MES/BMS validation, audit support
Preferred skills
German language, health authority inspection experience (FDA, Swissmedic)
Technologies
MODA, DeltaV
Responsibilities
Lead DI assessments for deviations and drive compliance initiatives; Lead and maintain CSV activities for MES, BMS, and production/lab equipment; Oversee validation of computerized systems for routine activities and CAPEX projects; Act as key QA contact for CSV providing expert guidance on validation strategies and document lifecycle; Partner with teams to support audits, inspections, and manage deviations/CAPAs/change controls.
Seniority
Senior, hands-on IC