Sterile QA Specialist (Shift) - Quality & Compliance

MSD Malaysia; Carlow; On-site; EUR 55,000 - 75,000; Full time

Job summary

MSD Malaysia is seeking an Associate Quality Assurance Specialist (Shift IPT) in Ireland to ensure cGMP quality oversight for IPT operations. The role requires supporting quality systems, investigations, and documentation reviews across multiple processes while driving a culture of continuous improvement.

The position works within a high-performing team, providing training and guidance on company guidelines and regulatory requirements, and ensuring audit readiness and product quality across the

Qualifications

• Experience with sterile filling processes and equipment.
• Lean Six Sigma methodology knowledge is desirable.
• Degree qualification in science, engineering, or technical field.
• Experience in sterile manufacturing is required.
• Strong written and verbal communication skills.
• Ability to learn and use computerized systems.
• Ability to work cross-functionally with precision.

Responsibilities

• Provide quality support to IPT production teams to ensure cGMP standards.
• Understand sterile manufacturing operations is preferred.
• Prioritize tasks and meet deadlines.
• Review batch documentation and line clearances for risk resolution.
• Liaise with other departments to promote GMP/Quality improvements.
• Keep abreast of regulatory developments affecting quality compliance.
• Support audits and audit readiness activities.
• Assist in customer complaint investigations if required.
• Support annual product quality reviews if required.

Skills

Sterile Filling

Lean Six Sigma

Influencing skills

Analytical skills

Problem solving

Computerized systems

Organizational skills

Customer focus

Collaboration

Decision making

Ethics & integrity

Education

Degree in Science/Engineering/Technical

Tools

SAP

Trackwise

MES

Job description

MSD Malaysia is seeking an Associate Quality Assurance Specialist (Shift IPT) in Ireland to ensure cGMP quality oversight for IPT operations. The role requires supporting quality systems, investigations, and documentation reviews across multiple processes while driving a culture of continuous improvement.

The position works within a high-performing team, providing training and guidance on company guidelines and regulatory requirements, and ensuring audit readiness and product quality across the