Quality Specialist - Quality Systems CoE

Next Generation Recruitment; Tipperary; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive salary

Job summary

Next Generation Recruitment is seeking a Quality Specialist - Quality Systems CoE to operate in a highly regulated pharmaceutical environment. The role supports GMP compliance, quality systems, auditing, laboratory quality, investigations, validation, and supplier activities across the site.

The candidate will identify compliance gaps, oversee CAPAs and deviations, and contribute to regulatory submissions and continuous improvement within a hybrid Ballydine-based setting.

Qualifications

• Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering, or a related technical discipline.
• Experience within the pharmaceutical or chemical industry, or a government drug-regulatory agency.
• Working knowledge of cGMP regulations.
• Pharmaceutical QA/QC experience, particularly with microbiology exposure.
• Experience with OOS/OOT investigations, environmental monitoring, analytical validation, or laboratory compliance.
• Knowledge of ICH Q2, USP/EP/JP requirements, and analytical or microbiological method validation.
• Experience with Kneat, ProCal, SAP, Quality Agreements, or Supplier Qualification.

Responsibilities

• Conduct routine audits of data, documentation, procedures, equipment, computer systems, and facilities against SOPs, GMP, and regulatory requirements.
• Prepare audit reports, communicate findings, and support remedial actions.
• Provide QA oversight of deviations, CAPAs, root-cause investigations, and quality trends.
• Support analytical and microbiological laboratory quality, including change controls and method validation, verification, and transfer.
• Provide oversight of environmental monitoring and microbiological control, including OOT/OOL investigations.
• Review equipment, utility, and facility qualification and validation documentation, including IQ/OQ/PQ.
• Coordinate Quality Agreements, Change Agreements, and Supplier Qualification activities.
• Support customer complaint investigations and material expiry/retest evaluations.
• Support SAP Master Data governance and material status and expiry updates.
• Contribute to regulatory submissions, GMP declarations, inspection readiness, and quality metrics.
• Contribute to continuous improvement across the Quality function.

Skills

GMP compliance

Auditing

Investigation

Quality systems

CAPA management

Root-cause analysis

Documentation

Communication skills

Change control

Education

Chemistry

Microbiology

Biology

Science

Pharmacy

Engineering

Tools

SAP

Kneat

ProCal

Job description

Strengthen Quality Through GMP & Quality Systems Expertise

Quality Specialist - Quality Systems CoE

Join a highly regulated pharmaceutical environment where your expertise will support GMP compliance, quality systems, auditing, laboratory quality, investigations, and validation .

We're looking for a quality professional who can work across a broad range of QA activities, identify compliance gaps, support investigations, and contribute to maintaining strong quality standards across the site.

What you'll achieve (and why it matters)

• Conduct routine audits of data, documentation, procedures, equipment, computer systems, and facilities against SOPs, GMP, and regulatory requirements.
• Prepare audit reports, communicate findings, and support remedial actions .
• Provide QA oversight of deviations, CAPAs, root-cause investigations, and quality trends .
• Support analytical and microbiological laboratory quality, including change controls and method validation, verification, and transfer .
• Provide oversight of environmental monitoring and microbiological control , including OOT/OOL investigations.
• Review equipment, utility, and facility qualification and validation documentation, including IQ/OQ/PQ.
• Coordinate Quality Agreements, Change Agreements, and Supplier Qualification activities.
• Support customer complaint investigations and material expiry/retest evaluations.
• Support SAP Master Data governance and material status and expiry updates.
• Contribute to regulatory submissions, GMP declarations, inspection readiness, and quality metrics .
• Contribute to continuous improvement across the Quality function.

Your edge (desired, not required)

• Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering, or a related technical discipline .
• Experience within the pharmaceutical or chemical industry , or a government drug-regulatory agency.
• Working knowledge of cGMP regulations .
• Pharmaceutical QA/QC experience , particularly with microbiology exposure.
• Experience with OOS/OOT investigations, environmental monitoring, analytical validation, or laboratory compliance .
• Knowledge of ICH Q2, USP/EP/JP requirements , and analytical or microbiological method validation.
• Experience with Kneat, ProCal, SAP, Quality Agreements, or Supplier Qualification .
• Exposure to Lean or Continuous Improvement methodologies.
• Strong written, verbal, interpersonal, organisational, and problem-solving skills.
• Ability to work hybrid in Ballydine, Co. Tipperary, typically 3 days onsite .

Why this role matters

You'll play a key role in maintaining GMP compliance and quality standards while gaining broad exposure across auditing, quality systems, laboratory quality, validation, investigations, supplier activities, and continuous improvement.

This role offers the opportunity to work across a varied Quality environment , rather than focusing on a single area of QA.

The next step for you

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