Overview
Quality Control Specialist III Jobs in Galway, County Galway, Ireland at HERO Recruitment
Title: Quality Control Specialist III
Company: HERO Recruitment
Location: Galway, County Galway, Ireland
Overview
An exciting opportunity has arisen for a Quality Control Specialist – Validation and Digital Data Quality (QAV/DDQ) to join a pioneering biopharmaceutical facility in Dunboyne. This role is ideal for an experienced quality assurance professional who thrives in a regulated environment and is passionate about driving operational compliance, digital excellence, and validation integrity. This position plays a pivotal role in maintaining high standards aligned with cGMP and global regulatory requirements, supporting both commercial and clinical operations.
Key Responsibilities
Lead Quality Oversight
Provides quality assurance oversight across Digital Data Quality and Validation functions, ensuring alignment with cGMP, FDA, HPRA, and EMEA regulations.
Compliance and Risk Management
Proactively engages in cross-functional teams to resolve compliance issues, perform risk assessments, and ensure timely implementation of corrective actions.
Project Involvement
Participates in all project phases – from design through commissioning and qualification – providing essential QA input and approvals.
Documentation and Change Control
Reviews and approves Change Controls, CAPAs, SOPs, and deviations, ensuring thorough compliance with internal and regulatory standards.
Validation Lifecycle Oversight
Manages validation activities, including review and approval of DQ, IQ, OQ, PQ, and PV protocols, with a focus on computerised system validation in accordance with GAMP and site policies.
Regulatory and Audit Readiness
Evaluates emerging regulatory trends and integrates best practices. Assists in internal audits and supports regulatory inspections, ensuring audit-readiness at all times.
Continuous Improvement
Champions continuous improvement initiatives across the QA function to drive quality, efficiency, and digital innovation.
Qualifications and Education
Minimum of 5 years’ experience in QA/Validation within a GMP-regulated biopharma or pharmaceutical environment.
Expertise in validation of computerised systems and process equipment (bioreactors, chromatography, autoclaves, etc.).
Strong understanding of GAMP, quality risk management (QRM), and regulatory inspection processes.
Proficient in quality systems such as Veeva Vault, TrackWise, SAP, and KNEAT.
Skilled in investigations, problem-solving, and root cause analysis as a QA SME.
Capable of delivering insights through Power BI and project management experience is highly desirable.
