QA CSV Specialist (m/f/d)

The QA CSV Specialist plays a key role in ensuring compliance and efficiency in the validation and lifecycle management of computerized systems. Reporting to the QA Validations & Qualifications Head, this position combines strategic process improvement with hands-on operational support, ensuring systems meet both regulatory requirements and business needs.Location: VispDuration: 12 months (possibility of extension)Workload: 100%Home office: 2 days per weekResponsibilitiesAct as QA liaison: Represent the QA department and serve as the primary contact for CSV-related matters with internal and external stakeholders.Ensure compliance: Monitor evolving industry regulations (GMP Annex 11, 21 CFR Part 11, GAMP, PIC/S) and integrate best practices into local policies and procedures.System validation: Oversee validation and lifecycle management of computerized systems (MES, Delta V, spreadsheets, bench-top equipment).Technical guidance: Provide expert IT input to support GMP decisions on system validation and lifecycle management.Continuous improvement: Develop and implement procedures, Validation Plans, and Master Plans to enhance efficiency and compliance.Project leadership: Define scope, create implementation plans, track progress, and proactively address risks to keep projects on schedule.Auditing: Conduct audits to ensure validation activities meet regulatory and corporate standards.Cross-functional collaboration: Partner with engineering, automation, and operations to assess new applications and define validation requirements.Escalation support: Act on behalf of the QA CSV Manager to ensure timely resolution of GMP issues.RequirementsEducation: Bachelor’s degree in Engineering, Information Technologies, Natural Sciences, or related field.Experience: 5–10 years in the pharmaceutical industry with advanced expertise in CSV and GMP regulations.Languages: English required; German is a plus.