Quality Systems Specialist - Compliance & CAPA Lead

Viatris; Sutton; On-site; EUR 50,000 - 68,000; Full time

Job summary

Viatris is seeking a Quality Systems Specialist to join McDermott Laboratories Limited. The role focuses on designing and implementing site Quality Systems to support the manufacture and release of combination products, ensuring regulatory compliance and robust CAPA processes.

You will collaborate with Engineering, Validation, Manufacturing and Regulatory teams, maintain document control, manage audits, and support training and continuous improvement initiatives across the site in Ireland.

Qualifications

• Educated to degree level with 3+ years industry experience.
• Working knowledge of EU & US regulatory requirements.
• Experience in designing and implementing quality systems and/or a start-up an advantage.

Responsibilities

• Develop and implement site Quality Systems to support manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review.
• Provide QA support to site to ensure Inspection Readiness.
• Collaborate with Engineering, Validation, Manufacturing, Regulatory and Global Quality to drive quality improvements.

Skills

Quality systems

Regulatory knowledge

Documentation control

Communication skills

Education

Bachelor's degree or higher

Tools

TrackWise

SAP

MS Office

Job description

Viatris is seeking a Quality Systems Specialist to join McDermott Laboratories Limited. The role focuses on designing and implementing site Quality Systems to support the manufacture and release of combination products, ensuring regulatory compliance and robust CAPA processes.

You will collaborate with Engineering, Validation, Manufacturing and Regulatory teams, maintain document control, manage audits, and support training and continuous improvement initiatives across the site in Ireland.