Computer System Validation Consultant (Sallent)

As a CSV L2 Consultant in Barcelona, you will take an active role in delivering high‑impact validation projects focusing on ERP systems and other critical computerized systems in regulated environments.

Key Responsibilities

• Lead CSV Projects:
  • Take ownership of ERP and other computerized system validations (IQ, OQ, PQ), preparing and reviewing critical documentation (VMP, URS, SOPs).
  • Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines.
• ERP & System Expertise:
  • Work hands‑on with ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADA, EBRs, pharmacovigilance, and maintenance systems.
  • Assess system compliance and performance to optimize regulatory readiness and operational efficiency.
• Audits & Compliance Assessments:
  • Perform supplier audits and compliance checks, focusing on Annex11, 21 CFR Part11, and global regulations.
  • Identify ris...