Leading Computer System Validation (CSV) activities throughout the system lifecycle
Developing validation strategies and documentation in accordance with GAMP® 5 (2nd Edition)
Supporting implementation and validation of regulated IT systems including ERP, LIMS, MES, Veeva Vault, eQMS and Document Management Systems
Performing GxP risk assessments and supplier assessments
Supporting audit and inspection readiness activities
Collaborating with business, IT, quality and external vendors across international project teams
Advising clients on best practices for Computer System Validation and Computer System Assurance (CSA)
What we’re looking for Minimum 5 years of experience in Computer System Validation (CSV) within the pharmaceutical, biotechnology or medical device industry.
Strong understanding of GAMP® 5, EU Annex 11, 21 CFR Part 11 and GxP requirements.
Experience with one or more of the following technologies: SAP, Veeva Vault, LabWare or Labvantage LIMS, MES, TrackWise, Document Management Systems,
ERP implementations.
Experience working in international project environments.
Fluent English (required) and German (preferred).
Excellent communication and stakeholder management skills.
Experience with Computer System Assurance (CSA), Data Integrity or Digital Quality is highly desirable.
Why join Qualitice? Work with some of the world's leading Life Sciences organisations.
Versátil remote‑first working model.
International projects across Germany, Switzerland and Europe.
Opportunity to work alongside highly experienced consultants on complex global transformation programmes.
Flexible collaboration models (permanent employment or freelance).
Join a fast‑growing specialist consultancy with an exclusive focus on Digital Quality & Compliance.
Compensation & Benefits Competitive hourly rates or salary depending on experience and engagement model.