CSV Consultant: Life Sciences Validation

Deloitte Ireland

Cork

Hybrid

EUR 41,000 - 50,000

Full time

2 days ago

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Job summary

Deloitte Ireland is seeking a Computerised System Validation (CSV) specialist to support clients in the Life Sciences and Healthcare sectors from Cork or Limerick with a hybrid working model. You will lead validation activities to ensure regulatory compliance and data integrity, leveraging GAMP 5 and risk-based approaches.

Key responsibilities include advising on CSV best practices, managing change controls, and driving inspection readiness.

Qualifications

Software/IT/Pharma/Science degree or related discipline.
Experience in IT-related field; familiarity with JIRA, Trackwise, Veeva Vault.
Understanding of SDLC with Agile or Waterfall.
Experience validating computerised systems with AI integration.
Experience in regulated industries and knowledge of GxP (GAMP, FDA/EMA).
Proficiency with MS Office Tools.
CAPA lifecycle and audit readiness experience.

Responsibilities

Prepare, execute and review CSV validation deliverables in line with FDA/EMA/ICH regs.
Advising clients in CSV best practice and regulatory compliance
Complete validation activities to client requirements
Support client in risk-based approach and identify process improvements
Provide CSV guidance to project teams for documentation and test defects
Monitor systems and processes to ensure SOP compliance and audit readiness
Manage validation change control docs and support CAPA/quality metrics
Apply risk-based validation to assess impact and ensure GAMP 5/data integrity
Drive inspection readiness activities including gap assessments and mock audits