Specialist QA CSV (Computer System Validation) (m/w/d)
Core
Specialist responsible for planning, executing, and continuously improving Computer System Validation (CSV) and Computer Software Assurance (CSA) for IT systems, applications, and databases in a GMP-regulated pharmaceutical manufacturing environment.
Role type
Specialist QA CSV (Computer System Validation)
Builds
Validated IT systems, applications, and digital processes for sterile injectable drug manufacturing
Domain
Pharmaceutical manufacturing / Computer System Validation (CSV)
Required skills
CSV/CSA methodology, GMP regulations, risk-based assessment, documentation management, CAPA processes, root cause analysis, stakeholder collaboration
Preferred skills
Data management, IT system validation, regulatory guidelines knowledge, trend analysis
Technologies
IT systems, databases, digital processes
Responsibilities
Evaluate existing/new IT systems for validation relevance, plan and coordinate CSV/CSA activities, participate in project requirements and documentation, review and maintain CSV documentation and SOPs, support root cause analysis and CAPA definitions, contribute to KPIs and trend analysis, present CSV/CSA topics in audits and inspections, collaborate with local and global teams