Quality Systems Specialist

Next Generation (Ireland); Dublin; On-site; EUR 65,000 - 82,000; Full time

Job summary

Next Generation (Ireland) is seeking a Quality Systems Specialist to join its pharmaceutical quality team in Dublin. This role focuses on enhancing the eQMS and ensuring robust regulatory compliance within a highly regulated environment.

You will oversee deviations, CAPAs, change controls and data integrity, support CSV, monitor KPIs with Power BI, and assist with audits and inspections. This maternity cover is 12-14 months and requires a strong QA background.

Qualifications

• 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.

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.

Skills

Quality systems management

eQMS administration

Deviations & CAPAs

Change controls

Audits & regulatory inspections

GMP/GDP knowledge

Data integrity

Regulatory compliance

Education

Bachelor's degree in Life Sciences or related field

Tools

TrackWise Digital

Power BI

Job description

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.

By submitting your details you agree to our Tnc