Quality Specialist
Employer · Viatris
Production engineer
Quality inspectorChemical engineerFull-timeKomárom
Ensuring as a lead that products not packaged by Mylan Hungary but released by them comply with EU GMP and Mylan requirements. The Quality Specialist coordinates change management processes, supports the introduction of new products, and collaborates with international teams.
Tasks
- Coordinating and tracking change management processes throughout their lifecycle
- Ensuring product compliance with marketing authorizations and monitoring regulatory changes
- Working closely with international Regulatory Affairs and quality teams
- Evaluating the quality and regulatory impact of planned changes
- Supporting the introduction of new products and product changes
- Managing and maintaining GMP-compliant documentation
- Preparing quality metrics and reports, and keeping databases up to date
- Providing professional support to participants in change management processes