Job Title: Quality Auditor Operations Specialist – Pharmaceutical Manufacturing (Shift-Based)
Location: Dublin, Ireland
Contract Type: Fixed-Term (11 Months)
Start Date: ASAP

Are you passionate about quality assurance in pharmaceutical manufacturing? This is a unique opportunity to work in a fast-paced, cutting-edge environment with a global healthcare leader known for innovation, excellence, and a strong commitment to employee growth.

Why Dublin?
Enjoy life in one of Europe’s most vibrant and welcoming cities—Dublin offers a rich cultural scene, a thriving biotech industry, and an outstanding quality of life with beautiful coastlines, lively communities, and easy access to the rest of Europe.

Key Responsibilities

• Provide on-the-floor quality support to production teams, ensuring compliance with GMP and regulatory standards.

• Review and approve executed Electronic Batch Records (eBRs), Master Batch Records (MBRs), and logbooks to ensure accuracy, data integrity, and adherence to procedures.

• Evaluate and approve Standard Operating Procedures (SOPs), Work Instructions, and controlled documents.

• Participate in shop floor activities, coaching teams to deliver right-first-time documentation and regulatory compliance.

• Support batch disposition activities and assist in deviation investigations when required.

• Serve as Quality SME for Performance Qualification (PQ) activities including cleaning validation, SIP, and equipment/process validation.

• Engage in the Tier process to identify and resolve quality-related issues in real time.

• Provide QA support across commissioning, qualification, and change management projects.

• Contribute to site audits and regulatory inspections, ensuring readiness and continuous improvement.

• Drive continuous improvement initiatives using problem-solving tools and Merck Production Systems (MPS) methodology.

Experience, Skills & Requirements

Required:

• Minimum 5 years’ experience in a GMP-regulated environment (pharmaceutical/biotech QA, operations, or laboratory settings).

• Strong working knowledge of QA operations, regulatory requirements, and GMP documentation practices.

• Demonstrated leadership and communication skills, with a proactive, team-oriented mindset.

• Hands-on experience in quality oversight of production processes and auditing activities.

Preferred:

• Background in pharmaceutical manufacturing, GMP auditing, and technical troubleshooting.

• Experience in coaching and mentoring peers on quality compliance.

• Strong analytical and problem-solving abilities.

Education

• Bachelor’s degree in a scientific or engineering discipline preferred. Equivalent experience in a regulated environment will also be considered.
  
  
  Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

  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.