Quality System Specialist

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.

Interested? Apply directly or get in touch to discuss the opportunity in more detail.