Quality Control Specialist III
Location: Dunboyne, Co. Meath

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.
  
  
  

For further information on this role please contact Hannah Talbot 
Phone: 086 107 0950
Email: engineering@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

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