Quality Assurance Specialist

QA Resources have an opportunity for a Sr QA Specialist role to be based on client site in East Cork:12 month initial contract, hybrid optionRole Overview

The Systems QA Specialist will provide Quality System (QMS) support and oversight within a sterile manufacturing environment operating terminal sterilisation in an aseptic filling setting.

This role focuses on maintaining and strengthening compliant quality systems to support safe, effective, and timely product supply. The successful candidate will work cross-functionally with Manufacturing, Engineering, Validation, QC Microbiology/Labs, and Supply Chain.

This is a support role and does not include final batch release authority but contributes to quality decision-making through assessment, documentation, and escalation in line with site procedures.

Responsibilities (may include but are not limited to):

• Support and maintain core QMS processes, including:
• Deviations / non-conformances
• CAPA management
• Change Control
• Risk Assessments
• Document Control and Training Compliance
• Ensure QMS records are progressed and closed on time in line with GDP and data integrity standards
• Support system health activities, including:
• Metrics and KPI tracking
• Trending and periodic reviews
• Continuous improvement initiatives
• Maintain inspection readiness through strong documentation, traceability, and audit support
• Support and/or coordinate change controls impacting sterile operations, including:
• Terminal sterilisation processes
• Equipment, utilities, and systems
• Validation and qualification alignment
• Provide QA systems support for terminal sterilisation activities
• Collaborate with QC Microbiology on system-level trending (e.g. environmental monitoring trends and excursions)
• Author, review, and maintain controlled documentation (SOPs, WIs, templates)
• Ensure training compliance and promote Good Documentation Practices (GDP)
• Support internal audits and regulatory inspections, including:
• Preparing documentation and evidence packs
• Supporting responses to observations
• Identify and support continuous improvement initiatives across QMS and sterile systems

Requirements:

• 5–10 years’ experience in a similar QA / Quality Systems role within a GMP-regulated environment
• Bachelor’s degree (or equivalent experience) in Science, Engineering, Pharmacy, or related discipline
• Strong experience with QMS processes, including:
• Deviations
• CAPA
• Change Control
• Documentation
• Strong understanding of GDP and data integrity requirements
• Excellent communication skills and ability to work cross-functionally

Desirable / Advantageous:

• Experience supporting terminal sterilisation processes and validation activities
• Familiarity with sterile manufacturing quality systems
• Experience with eQMS systems (e.g. TrackWise, Veeva, MasterControl, SAP QM)
• Previous audit or inspection experience
• Experience contributing to continuous improvement initiatives
• Experience in sterile or aseptic manufacturing environments

Interested candidates should send their CV to kellie.hackett@qaresources.com