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 option.
Role 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
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
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