eSystems Specialist - GMP/GxP Compliance & IT Support

Westbourne; Cork; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

Westbourne seeks an experienced eSystems Specialist to support the implementation, administration, maintenance and continuous improvement of electronic systems within a regulated environment. The role involves collaborating with Quality, IT, Engineering, Validation, Manufacturing and other functions to ensure compliance, effectiveness and alignment with business needs.

The successful candidate will help manage eQMS and other validated platforms, participate in CSV activities, and contribute to

Qualifications

• Experience with electronic systems in regulated environments (pharma, biotech, medical device).
• Understanding of GMP/GxP requirements and data integrity principles.
• Experience supporting system implementation, validation, upgrades or improvements.
• Strong documentation and stakeholder management skills.
• Ability to work with Quality, IT, Engineering, Manufacturing and business teams.
• Troubleshooting, analytical, and problem-solving capabilities.

Responsabilités

• Support implementation, configuration, administration and maintenance of electronic systems.
• Act as primary contact for users and stakeholders on system issues and improvements.
• Support systems such as eQMS, document management, LMS, laboratory, manufacturing or other validated platforms.
• Gather and document business and system requirements.
• Support system upgrades, testing and implementation activities.
• Participate in CSV and lifecycle documentation where required.
• Prepare and review user requirements, functional specs, test scripts, SOPs and validation docs.
• Support change controls, deviations, CAPAs, investigations and compliance activities.
• Ensure systems comply with GxP, data integrity and regulatory requirements.
• Manage user access, workflows and periodic system reviews.
• Troubleshoot issues with IT teams, vendors and stakeholders.
• Support user training and provide guidance on system functionality.
• Identify opportunities to improve system performance and business processes.
• Maintain accurate system documentation and audit trails for inspection.

Connaissances

Documentation

Stakeholder management

Troubleshooting

Analytical thinking

Problem solving

Outils

eQMS

Veeva

TrackWise

Documentum

SAP

LIMS

MES

LMS

Description du poste

Westbourne seeks an experienced eSystems Specialist to support the implementation, administration, maintenance and continuous improvement of electronic systems within a regulated environment. The role involves collaborating with Quality, IT, Engineering, Validation, Manufacturing and other functions to ensure compliance, effectiveness and alignment with business needs.

The successful candidate will help manage eQMS and other validated platforms, participate in CSV activities, and contribute to