Senior Quality Systems Specialist

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Senior Quality Systems Specialist

Solicitar locations Baldoyle, Dublin, Ireland time type Tiempo completo posted on Publicado hoy job requisition id R5661529 McDermott Laboratories Limited

En VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.

Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.

Lo hacemos a través de:

Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;

Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;

Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.

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 here's 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, we're 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 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

En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.

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