QA Executive Level III

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 Quality Assurance Executive will be responsible for assisting with the management of specific elements of the Quality Management System. These elements include the site change control procedure, deviation handling procedure, customer complaints and incoming inspection

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

• Lead specific Quality management system elements such as GMP investigations, Change Control, CAPA and  Risk Assessment and Customer Quality Complaints/Medical Device Vigilance systems.

• Support the Qualified person(s) to lead and perform data review audits (Batch Production Records, Validation Documents and Development Documentation, Quality Control Data as required)

• Support the Quality Manager in the definition and maintenance of the annual internal and external audit programs, Annual product reviews and Quality management reviews for Mylan.

• Manage and Maintain the site Vendor Management System

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

• Review and approve suppliers / service providers including supporting with audits of critical suppliers where required

• Support the Quality Manager with hosting external audits and regulatory inspections

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

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

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:

• Minimum of a Bachelor's degree (or equivalent) in a Science or engineering related discipline and at least 5years relevant experience within a relevant sector (i.e pharmaceutical/medical device industry) with a minimum of 3 years’ experience within a Quality Assurance role.

• Experience of sterile manufacturing desirable but not essential.

• Experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, and batch release.

• Experience of TrackWise or similar electronic document management systems is highly desirable

• Excellent communication (oral & written) and presentation skills.

• Ability to handle multiple tasks in a fast paced environment with strong organisational and time management skills.

• Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (Word, Excel, Powerpoint etc.)

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 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.