Job Description

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/  

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.