Quality Assurance Specialist, Device Development Assurance
2 months ago
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
The Quality Assurance Specialist will be responsible for supporting the ongoing maintenance and improvement of the Quality Management System. The Quality Assurance Specialist is responsible for compiling, analysing and presenting data to measure and report on the organisation's performance against established quality objectives, ensuring continuous improvement and compliance with regulatory requirements.
Every day, we rise to the challenge to make a difference and here’s how the Quality Assurance Specialist, Device Development Assurance role will make an impact:
Provide Quality oversight of development laboratory activities against local Global Device Development (GDD) procedures, Global Viatris Policies, and product specific requirements, including but not limited to:
Test Equipment Management – Qualification, Calibration, Preventative Maintenance, Traceability
Material controls – Receipt, Inspection, Storage and Traceability
Test Method Validation
Stability product management oversight
Continuous Improvement – Procedures, Work Instructions, CAPA, Investigations
Support the general development and improvement of the GDD Quality System through management of CAPA, Internal Audit program, documentation, complaints, trending and training
Support third-party inspections/audits
Quality oversight of development laboratory activities
Support CAPA, Internal Audit program, documentation, complaints, trending and training
Support third-party inspections/audits
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:
Bachelor’s degree in Science, Engineering or Biotechnology
Minimum 3-5 years relevant professional experience (GMP / Medical Device Industry quality operations)
Demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745
Strong problem solving and analytical skills
Possess knowledge of core manufacturing / laboratory operation principles
Excellent communicator; clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established timelines
A team player willing to support any other organisational needs/activities outside primary expertise to continuously develop the business
Demonstrated ability to perform in a high-performing workforce
Ability to work independently and with minimal direction
Ability to define, organize, and manage individual and team tasks
Proficient in MS Office applications
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.
Benefits at 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. Some of our benefits include the following on top of a competitive salary:
Excellent career progression opportunities
Work-life balance initiatives
Bonus scheme
Health insurance
Pension
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
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
At Viatris, we offercompetitivesalaries, benefitsandan 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.
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