Quality Operations Specialist — On-the-Floor GMP Expert

MSD Ireland; Leinster; On-site; EUR 60,000 - 90,000; Full time

Job summary

MSD Ireland is seeking a Quality Operations Specialist for our Dundalk vaccine facility. You will provide direct QA support to manufacturing operations, ensure GMP and documentation compliance, and represent quality on the shop floor across Drug Product and Drug Substance GMP manufacturing.

Key activities include reviewing batch records and production docs, participating in the Tier process, and supporting change controls and audits while driving a proactive quality culture.

Qualifications

• Bachelor’s degree in a scientific or engineering field such as Biotechnology, Microbiology, or related Life Sciences.
• Minimum 3 years of experience in a regulated GMP manufacturing, Quality Assurance, or laboratory environment.
• Practical working knowledge in the biopharmaceutical or vaccine industry, specifically within Quality Assurance operations.
• Strong interpersonal skills, including flexibility, empathy, collaboration, and the proven ability to thrive in an inclusive team environment.

Responsibilities

• Review and approve Master Batch Records and Electronic Batch Records.
• Review and approve production documentation to ensure GMP compliance.
• Maintain active shop-floor presence to support compliance and data integrity.
• Review and approve SOPs, work instructions, and controlled job aides.
• Participate in site Tier process to surface quality issues and drive swift resolution.
• Provide QA support for commissioning and qualification lifecycle documents for capital projects and equipment.
• Serve as SME for PQ activities across the site (equipment, utilities, validation, and cleaning).
• Collaborate on cross-functional projects and continuous improvement initiatives.
• Support change control, deviation investigations, CAPAs, requalification, and calibration programs.
• Support internal audits and regulatory inspections; promote inspection readiness.

Skills

Interpersonal skills

Flexibility

Empathy

Collaboration

Teamwork

Education

Bachelor’s degree in a scientific or engineering field

Tools

Quality Management Systems (QMS)

Job description

MSD Ireland is seeking a Quality Operations Specialist for our Dundalk vaccine facility. You will provide direct QA support to manufacturing operations, ensure GMP and documentation compliance, and represent quality on the shop floor across Drug Product and Drug Substance GMP manufacturing.

Key activities include reviewing batch records and production docs, participating in the Tier process, and supporting change controls and audits while driving a proactive quality culture.