Quality Systems Specialist - Compliance & Continuous Improvement

Viatris; Dublin; On-site; EUR 65,000 - 80,000; Full time

Benefits offered by this job

Competitive salaries

Inclusive environment

Job summary

Viatris Ireland is hiring a Quality Systems Specialist to design and implement site Quality Systems for combination products, including SOPs, CAPA, investigations and internal audits. You will collaborate with Engineering, Validation, Manufacturing and Regulatory teams to maintain inspection readiness, support regulatory reviews and drive continuous improvement.

Degree plus 3+ years' experience, and proficiency with TrackWise, SAP and MS Office are required.

Qualifications

• Degree-level education with 3+ years industry experience.
• Experience designing and implementing quality systems.
• Knowledge of EU & US regulatory requirements.
• Proficiency with TrackWise, SAP and MS Office.
• Ability to work flexibly in a changing environment; strong attention to detail.

Responsibilities

• Develop and implement site Quality Systems for combination products (SOPs, document control, change control, investigations, CAPA, internal auditing, vendor qualification).
• Provide QA support to ensure inspection readiness.
• Collaborate with Engineering, Validation, Manufacturing, Regulatory and Global Quality.
• Support operation of the site Training system and prepare relevant training material.
• Regulatory compliance; support Dublin Respiratory reviews and generation of supporting documents.
• Keep abreast of regulatory initiatives and new guidance/requirements.
• Drive continuous improvement in product and process quality; ensure EH&S compliance.
• Support and execute other duties as assigned.

Skills

Quality systems

Regulatory knowledge

Documentation

Attention to detail

Communication

Team collaboration

Adaptability

Education

Bachelor's degree (or higher)

Tools

TrackWise

SAP

MS Office

Job description

Viatris Ireland is hiring a Quality Systems Specialist to design and implement site Quality Systems for combination products, including SOPs, CAPA, investigations and internal audits. You will collaborate with Engineering, Validation, Manufacturing and Regulatory teams to maintain inspection readiness, support regulatory reviews and drive continuous improvement.

Degree plus 3+ years' experience, and proficiency with TrackWise, SAP and MS Office are required.