CSV & Data Integrity Lead — GxP Validation

GE HealthCare

Ireland

On-site

EUR 120,000 - 150,000

Full time

3 days ago

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Job summary

GE HealthCare in Ireland seeks an experienced lead for Computerized Systems Validation (CSV) & Data Integrity to maintain and enhance the site validation framework and data governance. You will partner with Engineering, Quality, Manufacturing, IT and external suppliers to ensure compliant lifecycle management of computerized systems.

Role requires strong regulatory knowledge, cross-functional collaboration, and leadership in CS validation activities across the lifecycle, with attention to ALCOA+

Qualifications

Significant experience leading CSV activities across full lifecycle.
Strong knowledge of data integrity principles and ALCOA+.
Familiarity with EU GMP Annex 11 and FDA/CSA methodologies.

Responsibilities

Own and improve CSV and Data Integrity procedures and governance.
Review site inventory of GxP computerized systems.
Ensure validation activities meet regulatory requirements and best practice.
Develop validation strategies, plans, risk assessments, and test protocols.
Maintain traceability matrices and data lifecycle documentation.
Lead Data Integrity assessments and continuous improvement initiatives.
Support regulatory inspections, audits and responses.

Skills

CSV leadership

Data Integrity

Regulatory compliance

GxP systems

CSA methodologies

Cross-functional collaboration

Change management

Education

Degree in Engineering/CS/Life Sciences

Tools

TrackWise

DCS/SCADA

Job description

Role requires strong regulatory knowledge, cross-functional collaboration, and leadership in CS validation activities across the lifecycle, with attention to ALCOA+

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