QA Operations Specialist - On‑Floor GMP & Compliance

MSD Malaysia; Leinster; On-site; EUR 60,000 - 85,000; Full time

Job summary

MSD is seeking a Quality Operations Specialist at our Dundalk vaccine facility to provide direct quality support to manufacturing operations on the shop floor. You will ensure quality and compliance with GMP and documentation practices while partnering with cross-functional teams to drive continuous improvement.

Ideal candidates will hold a Bachelor’s degree in a scientific/engineering field and have at least 3 years in GMP QA or related labs.

Qualifications

• 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.
• Preferred 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.

Responsibilities

• Review and approve new and updated Master Batch Records and Electronic Batch Records.
• Review and approve production documentation, such as executed electronic batch records and logbooks, for GMP compliance.
• 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.
• Participate in the site Tier process to make quality matters visible and partner with operations on swift resolution.
• Provide QA support, review, and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Serve as the QA SME for Performance Qualification activities across the site, including equipment, clean utilities, facility qualification studies, Cleaning Validation, Sterilise-in-Place, and process validation.
• Collaborate on cross-functional site projects as a quality partner.
• Support change control, deviation investigations, CAPAs, requalification, periodic reviews, and calibration programs.
• Provide direct support to internal audits and external regulatory inspections, maintaining inspection readiness.
• Collaborate on continuous improvement initiatives and action plans.
• Drive continuous improvement and use structured problem-solving to enhance efficiency and promote a quality culture.

Skills

Audit Readiness

Change Controls

Deviation Management

Documentation Review

GMP

QMS

Quality Operations

Education

Bachelor’s degree in science/engineering

Job description

MSD is seeking a Quality Operations Specialist at our Dundalk vaccine facility to provide direct quality support to manufacturing operations on the shop floor. You will ensure quality and compliance with GMP and documentation practices while partnering with cross-functional teams to drive continuous improvement.

Ideal candidates will hold a Bachelor’s degree in a scientific/engineering field and have at least 3 years in GMP QA or related labs.