Quality System Specialist

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

Quality System Specialist – Digital/Administrator | Dublin

We are looking for an experienced Quality Specialist to support a major Digital QMS implementation/upgrade within a pharma manufacturing organisation in Dublin.

This role would suit a Quality professional with strong Digital QMS / System Administration experience who understands the technical side of Quality systems beyond standard end-user activities. You will play a key role in supporting the upgrade, testing, deployment and stabilisation of the organisation's QMS platform.

Key Responsibilities

• Support the preparation, testing and deployment of a new Digital QMS version.
• Provide operational Quality support throughout the system upgrade and transition.
• Support system administration activities, including user management, configuration and ongoing system support.
• Work closely with Process Owners to understand business requirements and support the setup and optimisation of workflows.
• Support CSV activities associated with the system upgrade and deployment.
• Ensure data integrity, GxP compliance and system control throughout the transition.
• Update relevant SOPs, system documentation and Quality documentation.
• Support users during deployment and contribute to post-go-live system stabilisation.
• Collaborate with IT, System Owners, Process Owners and global Quality teams.
• Contribute to the continuous improvement and optimisation of digital Quality processes.

Required Experience

• 5+ years' experience within a GxP-regulated environment such as Pharmaceutical, Biotechnology or Medical Devices.
• Strong experience working with an Electronic Quality Management System (eQMS / Digital QMS).
• Previous experience operating as a System Administrator or equivalent, rather than solely as an end user.
• Experience with Ennov is highly desirable; candidates with strong Veeva Vault QualityDocs/QMS or TrackWise experience will also be considered.
• Experience supporting system upgrades, implementations, deployments or major configuration changes.
• Good understanding of Computerised System Validation (CSV).
• Strong knowledge of EU GMP Annex 11 and GAMP 5 principles.
• Understanding of workflow configuration, user roles, permissions and system administration within a regulated Quality environment.
• Ability to translate Quality/process requirements into appropriate system workflows and configurations.
• Strong communication skills with the ability to work across Quality, IT and business stakeholders globally.

Ideal Profile

We are particularly interested in candidates who sit at the intersection of Quality and Digital Systems – someone who understands GxP Quality processes but is also technically comfortable working with administrators, process owners and IT teams during an eQMS upgrade.

Experience supporting an Ennov, Veeva or TrackWise upgrade/implementation would be particularly valuable.