QA Operations Specialist

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

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.

What you will do

• 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.

What skills you will need

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.
• 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.

Required Skills

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

Preferred Skills

• Secondary Language(s)

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing inclusive, talented, and committed people together. So, if you are ready to: Invent solutions to meet unmet healthcare needs.

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 10/2/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.