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.