Digital QMS Specialist – eQMS & CSV Expert

ARTO; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

ARTO in Dublin seeks an experienced Quality System Specialist to support a major Digital QMS upgrade within a pharma manufacturing environment. You will drive system administration, user management, and workflow configuration while coordinating with Process Owners and IT to ensure data integrity, GxP compliance, and a smooth deployment and post-go-live stabilization.

The role requires strong experience with eQMS such as Ennov, Veeva Vault QMS or TrackWise; knowledge of CSV and GAMP5 is highly

Qualifications

• 5+ years in a GxP-regulated environment (Pharma/biotech/medical devices).
• Experience with electronic QMS (eQMS/Digital QMS).
• Experience as System Administrator, not only end-user.
• Experience upgrading/enhancing Ennov, Veeva Vault QMS or TrackWise.
• Knowledge of CSV and software validation (CSV).
• Strong knowledge of EU GMP Annex 11 and GAMP5.
• Ability to translate quality requirements into system workflows.

Responsibilities

• Support preparation, testing and deployment of a new Digital QMS version.
• Provide operational Quality support during upgrade and transition.
• System administration: user management, configuration and ongoing support.
• Collaborate with Process Owners to set up workflows.
• Support CSV activities for upgrade/deployment.
• Maintain data integrity, GxP compliance, and system controls.
• Update SOPs and system documentation.
• Assist post-go-live stabilisation.
• Collaborate with IT, System Owners, Process Owners and global Quality teams.
• Contribute to digital Quality process improvements.

Skills

Quality systems

GxP compliance

CSV

System administration

Cross-functional collaboration

Tools

Ennov

Veeva Vault QMS

TrackWise

Job description

ARTO in Dublin seeks an experienced Quality System Specialist to support a major Digital QMS upgrade within a pharma manufacturing environment. You will drive system administration, user management, and workflow configuration while coordinating with Process Owners and IT to ensure data integrity, GxP compliance, and a smooth deployment and post-go-live stabilization.

The role requires strong experience with eQMS such as Ennov, Veeva Vault QMS or TrackWise; knowledge of CSV and GAMP5 is highly