Quality Assurance Specialist (maternity leave replacement)

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via: 
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and services. 
 

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. 

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world 

The Role & What You Will Be Doing 

• Participate in maintenance of the Affiliate Quality Management System in line with European, local regulations and Viatris product quality related corporate requirements for Viatris Hrvatska d.o.o. and Viatris BH d.o.o.
• Responsible as a backup person for QA topics with regards to product quality in Croatia and in Bosnia and Herzegovina

Every day, we rise to the challenge to make a difference and here’s how the Quality Assurance Specialist role will make an impact:  

•  Participating in the establishment, implementation, maintenance, and compliance of the quality management system with EU GDP regulations for Croatian market
• Prepare local Quality SOPs and other documents according to GxP practice relevant to the quality activities in Croatia, and Bosnia and Herzegovina
• Participate in recalls, mock-recalls and withdrawals in the territories according to applicable regulations and Viatris requirements
• Managing with customer complaints
• Managing with local training procedure
• Prepare, implement and review of quality agreements
• Evaluate and review of Product Quality Reviews (PQR)
• Participate in serialization topics in order to ensure compliance with the Falsified Medicines Directive for products distributed in Croatia
• Participate in Self-Inspections and audits periodically according to Viatris policy
• Participate in QA deviations and CAPAs

About Your Skills & Experience 

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:  

•  University degree (Medical, Pharmacy or similar scientific background)
• Fluent English both in speaking and writing
• Minimum 2 years working in the pharmaceutical industry in quality assurance or similar positions is preferred
• Experience in GxP area (GDP/GMP) is preferred
• Knowledge of Croatian pharmaceutical regulation with focus on Quality Assurance
• Knowledge of Bosnia and Herzegovina pharmaceutical regulation with focus on Quality Assurance is preferred
• Knowledge of EU pharmaceutical regulation with focus on Quality Assurance is preferred
• Experience with TW and SAP is a benefit
• Practical knowledge of Microsoft Office

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. 

Why Viatris? 

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives. 

Diversity & Inclusion at Viatris 

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion  

Sustainability at Viatris 

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility  

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.