Quality Systems Specialist, CoE — GMP & CAPA Leader

Recruitment by Aphex; Tipperary; On-site; EUR 70,000 - 100,000; Full time

Job summary

The Contract Associate Quality Specialist at the Ballydine facility supports day-to-day QA activities, ensures cGMP compliance, and contributes to continuous improvement within the Quality Systems Centre of Excellence.

You will oversee quality agreements, supplier qualification, deviations and CAPAs, plus validation lifecycles, environmental monitoring, and laboratory method validation, providing QA oversight across analytical and microbiological operations.

Qualifications

• Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering.
• Direct experience in quality systems, GMP compliance and deviation management.
• Knowledge of laboratory validation and environmental monitoring is required.

Responsibilities

• Quality Systems, Investigations & CAPA oversight for deviation investigations and root-cause analysis.
• Manage supplier qualification, QA agreements, and change controls.
• Oversee analytical/microbiological labs, method validation, and data integrity.

Skills

Quality assurance

CAPA management

Deviations root cause

QA governance

Analytical QA support

Education

Degree in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering

Tools

Kneat

ProCal

SAP

Job description

The Contract Associate Quality Specialist at the Ballydine facility supports day-to-day QA activities, ensures cGMP compliance, and contributes to continuous improvement within the Quality Systems Centre of Excellence.

You will oversee quality agreements, supplier qualification, deviations and CAPAs, plus validation lifecycles, environmental monitoring, and laboratory method validation, providing QA oversight across analytical and microbiological operations.