GMP Quality Systems Specialist - Hybrid Role

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

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.