Quality Systems Specialist

Quality Systems Specialist - Pharmaceutical

Location: Dublin, Ireland

Contract: 12-14 Months (Maternity Cover)

Role Overview

Ready to make an impact and drive quality systems excellence?

We are seeking an experienced Quality Systems Specialist to join a dynamic pharmaceutical organisation, taking a key role in enhancing quality systems, driving eQMS improvements and strengthening regulatory compliance.

This is an excellent opportunity to take ownership of critical quality processes, collaborate with cross-functional teams and contribute to continuous improvement within a highly regulated pharmaceutical environment.

Key Responsibilities

• Manage and continuously improve electronic Quality Management Systems (eQMS).
• Oversee deviations, CAPAs, change controls and quality risk assessments.
• Support eQMS administration, system configuration, upgrades and workflow improvements.
• Ensure compliance with GMP, GDP, GAMP 5 and EU GMP Annex 11.
• Support computerised system validation (CSV) and data integrity requirements.
• Monitor quality KPIs, metrics and trends, including Power BI reporting.
• Support regulatory inspections, internal audits and supplier qualification.
• Contribute to quality improvement initiatives and operational QA activities.

Requirements

• Degree in Life Sciences, Biochemistry, Microbiology or a related discipline.
• 5-7 years' pharmaceutical Quality Assurance experience.
• Strong hands-on eQMS administration and QMS experience.
• Experience with deviations, CAPAs, change controls and audits.
• Knowledge of GMP/GDP, data integrity, CSV and GAMP 5.
• Experience with quality metrics, reporting and supplier oversight.
• TrackWise Digital and Power BI experience desirable.
• Strong communication, organisational and problem-solving skills.

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