QA Operations Specialist at Merck in IRL - Louth County - Dundalk

Job description

• An amazing opportunity has arisen for a Quality Operations Specialist, at our newest state-of-the-art, fully integrated vaccine facility in Dundalk.
• This role provides direct quality support and oversight to manufacturing operations as part of an integrated cross-functional team. With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures the quality and compliance of products manufactured on site, adherence to Good Manufacturing and Documentation Practices, and represents quality directly on the shop floor across Drug Product and Drug Substance GMP manufacturing.

Responsibilities

• Bring energy, knowledge, innovation, and leadership to carry out the following:
• Responsible for the review and approval of new and updated Master Batch Records and Electronic Batch Records.
• Review and approve production documentation, such as executed electronic batch records and logbooks, to ensure accuracy and compliance with current Good Manufacturing Practice and company procedures.
• Maintain an active presence on the shop floor to support compliance, data integrity, and right-first-time manufacturing.
• Review and approve new and updated Standard Operating Procedures, work instructions, and controlled job aides.
• Actively participate in the site Tier process, using this forum to make quality matters visible and to partner with operational areas on swift resolution.
• Provide Quality Assurance support, review, and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Serve as the Quality Subject Matter Expert for Performance Qualification activities across the site, including equipment, clean utilities, facility qualification studies, Cleaning Validation, Sterilise-in-Place, and process validation.
• Participate as an active, collaborative quality partner on site cross-functional projects.
• Support sustaining activities such as change control management, deviation investigations, Corrective and Preventive Actions, equipment requalification, periodic reviews, and the site maintenance and calibration programme.
• Provide direct support to internal audits and external regulatory inspections, fostering ongoing inspection readiness.
• Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
• Drive continuous improvement and utilise structured problem-solving tools to enhance operational efficiency, resolve issues, and promote a proactive quality culture.

Requirements

• In order to excel in this role, you will more than likely have:
• Required
• Bachelor’s degree in a scientific or engineering field (such as Biotechnology, Microbiology, or related Life Sciences).
• Minimum 3 years of relevant experience in a regulated Good Manufacturing Practice 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.
• Experience with Quality Management Systems, pharmaceutical manufacturing or laboratory processes, and authoring and approving Good Manufacturing Practice documents. Advantage if participated to the implementation, deployment of QMS.
• Demonstrated analytical aptitude, critical thinking skills, and practical problem-solving capabilities.
• Demonstrated leadership qualities with strong, constructive oral and written communication abilities.
• Bioprocessing knowledge, aseptic manufacturing experience, or technical transfer familiarity.
• Audit Readiness, Change Controls, Deviation Management, Documentation Review, Good Manufacturing Practices (GMP), Quality Management Systems (QMS), Quality Operations

Skills

Required

• Audit Readiness
• Change Controls
• Deviation Management
• Documentation Review
• Good Manufacturing Practices (GMP)
• Quality Management Systems (QMS)
• Quality Operations

Preferred

• Authoring and approving GMP documents
• Implementation, deployment of QMS
• Analytical aptitude
• Critical thinking skills
• Practical problem-solving capabilities
• Leadership qualities
• Bioprocessing knowledge
• Aseptic manufacturing experience