Overview
Quality Auditor Jobs in Dublin, County Dublin, Ireland at MSD Ireland
Title: Quality Auditor
Company: MSD Ireland
Location: Dublin, County Dublin, Ireland
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.
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.
