GxP eSystems Specialist — CSV & QMS Expert

Westbourne IT Global Services; Cork; On-site; EUR 65,000 - 90,000; Full time

Job summary

Westbourne IT Global Services is seeking an experienced eSystems Specialist to support implementation, administration, and continuous improvement of electronic systems in a regulated environment. You will collaborate with Quality, IT, Engineering, Validation, Manufacturing, and other functions to ensure compliance and system effectiveness.

Your role includes supporting system upgrades, validation activities, user training, and documenting requirements, test scripts, and validation artifacts.

Qualifications

• Experience with electronic systems in a regulated environment (pharma/biotech/medical device).
• Knowledge of platforms like eQMS, Veeva, TrackWise, Documentum, SAP, LIMS, MES or LMS.

Responsibilities

• Support implementation, configuration, administration, and maintenance of electronic business and quality systems.
• Act as primary contact for users and stakeholders on system queries, issues, and improvements.
• Support CSV and system lifecycle documentation where required.
• Prepare and review user requirements, functional specs, test scripts, SOPs, and validation documentation.
• Assist with change controls, deviations, CAPAs, investigations, and compliance activities.
• Ensure systems maintain data integrity and comply with GMP/GxP requirements.

Skills

eSystems

GxP compliance

CSV knowledge

document management

Quality/IT collaboration

Regulatory audits

Tools

eQMS

Veeva

TrackWise

Documentum

SAP

LIMS

MES

LMS

Job description

Westbourne IT Global Services is seeking an experienced eSystems Specialist to support implementation, administration, and continuous improvement of electronic systems in a regulated environment. You will collaborate with Quality, IT, Engineering, Validation, Manufacturing, and other functions to ensure compliance and system effectiveness.

Your role includes supporting system upgrades, validation activities, user training, and documenting requirements, test scripts, and validation artifacts.