Senior QA Executive

Mylan Teoranta

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 Senior Quality Assurance Executive will be responsible for assisting with the co-ordination of all elements of the Quality System assigned to the Quality Assurance Department.

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

• Manage core competencies activities of the team.

  • Quality Management Systems: Management of Investigations, CAPA & LIRs, Trend Assessments, Risk Assessment, Customer Complaints, APR/PQR, Management review implementation.

  • SOP review for compliance to Guidance and Global Policy and maintaining the revision on GMP documentation within the team

  • Act as Quality Subject Matter expert in Quality System activities where required, for example in Trackwise

  • Create, maintain and deliver training in quality related topics to Viatris personnel Support the Quality Assurance team in preparation of monthly/quarterly/annual reports to be submitted to senior management and Viatris departments to ensure visibility of QMS requirements and performance including the compilation of quality metrics to facilitate monitoring and management of the Viatris Quality System

• Act as the site Investigation Lead. Review retrospective review of investigations completed by the Global Quality Investigations group and implement process improvements. Monitor and respond to key performance indicators from the investigational metrics.

• Work with cross functional teams as required to implement global quality policies and compliance improvement initiatives as they relate to pharmaceuticals and medical devices and site quality model. Challenge areas of technical compliance with responsible parties.

• Participate in site Internal audit program and support external and regulatory inspections as required.

• Provide technical compliance guidance and support in relation to all products as required to all personnel at the site.

• Support the quality organization to meet the needs of the growing business; using technical expertise, skills knowledge and experience as required to resolve problems and share knowledge

• May act as principal project quality lead for new and existing Viatris projects providing advice and guidance to operational teams with support and guidance from the Quality Manager.

• Manage and mentor more junior members of the team as required.

• Act as Manager approver in absence of Manager as requested.

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 (or equivalent) in a Science related discipline with 8+ years in Pharmaceutical/ Medical Device Quality Assurance/Control or related department is essential Experience with management of investigations and CAPA. Experience in either a Quality Assurance or Regulatory Affairs role essential.

• Ability to handle multiple tasks in a fast paced environment.

• Experience of Quality Operations and Lean operational systems in manufacturing is beneficial.

• Working knowledge of DMAIC, 6-Sigma management tools, statistical analysis and trending

• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.

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 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.