Senior Quality Systems Specialist
Senior Quality Systems Specialist
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Job Description
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
Every day we rise to the challenge to make a difference and heres how the Senior Quality System Specialist role will make an impact:
Collaborate with manufacturing and engineering functions to drive quality awareness facilitate Good Manufacturing Practices and implement improvements to ensure product quality
Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality.
Conduct checks and reviews of manufacturing operations to monitor factors which may affect product quality.
Review and evaluate all internal executed batch records to facilitate disposition of product for Batch release
Review externally manufactured product documentation
Participate in site commissioning and qualification program
Review and participate in all deviations and changes to manufacturing operations to ensure appropriate investigation and assessment carried out and actions implemented and monitored.
Support complex site and 3rd party investigations present issues to the QP in clear and concise manner
Management of On Hold & Reject lists for the site
Ensure continued product quality through the Quality System by: Supporting product launches and commercial activities by coordinating with third parties managing change controls and preparing key regulatory documents. Maintaining oversight of manufacturing operations contributes to PQRs participates in self-inspections and ensures alignment with regulatory guidelines through active use of Quality Risk Management and training support.
About Your Skills & Experience
For this role were looking for a candidate who has an effective combination of the following qualifications skills and experiences:
Educated to degree level with proven industry experience
Working knowledge of EU & US regulatory requirements
Experience with Investigational Medicinal Products manufacturing an advantage
Experience in or knowledge of inhalation dosage forms an advantage.
Good team working and strong communication skills across functions and organization.
At Viatris we are dedicated to building a truly diverse inclusive and authentic workplace so if youre excited about this role but your past experience doesnt 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 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 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.
Required Experience:
Senior IC
Employment Type
Full-Time
