Planet Pharma

Computer System Validation (CSV) Lead – Planet Pharma – Leiden

jobid=A.0.0564

Hiring: CSV Lead – GMP Environment | 5–10+ Years Experience

We’re looking for a Computer System Validation (CSV) Lead to join a dynamic team supporting facility startup and inspection readiness in a GMP-regulated setting.

What you’ll do:

  • Build and implement a full CSV strategy and documentation framework
  • Validate QMS, SCADA/BMS/EMS, SAP, and analytical software (e.g., Waters HPLC, Labguru)
  • Lead system impact assessments and maintain GxP system inventory
  • Apply GAMP 5, Annex 11, and 21 CFR Part 11 principles
  • Collaborate cross-functionally with QA, IT, and business units

What we’re looking for:

  • 5–10+ years in CSV roles within GMP environments
  • Proven experience in facility startup and regulatory inspections
  • Strong documentation and risk-based validation expertise

#CSV #GAMP5 #GMP #Validation #PharmaJobs #Hiring #ERP #SCADA #SAP #QualitySystems

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

Lees hier meer

Deel deze vacature: