Quality Systems Specialist, GMP/GDP Compliance

Viatris; Dublin; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is a global healthcare company delivering branded and generic medicines worldwide. The Quality System Specialist role focuses on review of GxP documentation, product complaints, change controls, PMSI and CAPA implementation, and maintaining QTAs with suppliers to ensure GDP/compliance.

The candidate will manage product returns, vendor approvals, and annual supplier reviews, while supporting QMS development across the organisation and ensuring audit readiness.

Qualifications

• Experience in Quality Assurance, Quality Systems or Quality Compliance within pharma.
• Strong knowledge of GMP, GDP and QMS.
• Experience managing deviations, investigations, root cause analysis and CAPAs.
• Experience coordinating Change Controls through to closure.
• Experience with supplier/vendor qualification and quality oversight.

Responsibilities

• Review third party GxP documentation to support batch disposition of respiratory products.
• Manage and review product complaints.
• Coordinate change control system per SOPs and close open items.
• Manage PMSI and deviation systems, raise records in TrackWise, assist investigations and ensure CAPAs are implemented.
• Ensure QTAs are in place with suppliers/service providers as appropriate.
• Manage product returns per GDP guidelines.
• Coordinate approval of new vendors and customers per GDP guidelines.
• Carry out annual Bona Fide checks on suppliers and customers.
• Maintain and update the department’s training and Learning Management systems.
• Support self-inspection and development of QMS at EU region.

Skills

QA experience

GMP/GDP knowledge

TrackWise experience

Deviation investigations

Education

Degree in scientific/pharmaceutical discipline

Tools

TrackWise

Job description

Viatris is a global healthcare company delivering branded and generic medicines worldwide. The Quality System Specialist role focuses on review of GxP documentation, product complaints, change controls, PMSI and CAPA implementation, and maintaining QTAs with suppliers to ensure GDP/compliance.

The candidate will manage product returns, vendor approvals, and annual supplier reviews, while supporting QMS development across the organisation and ensuring audit readiness.