Quality Systems Specialist

Quality Systems Specialist (12 months fixed term contract) page is loaded

Quality Systems Specialist (12 months fixed term contract)

Apply locations Baldoyle, Dublin, Ireland time type Full time posted on Posted Today job requisition id R5661110 McDermott Laboratories Limited

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 here's how the Quality Systems Specialist role will make an impact:

- Develop and implement site Quality Systems to support the manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review.

- Provide QA support to site to ensure Inspection Readiness.

- Collaborate with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality.

- Support operation of the site Training system, including preparing and presenting relevant training material, as required.

- Regulatory Compliance; support Dublin Respiratory reviews and generation of supporting documents including API Declaration, Approved Product List, Approved Oversight List.

- Keep abreast of regulatory initiatives and new guidance/requirements.

- Ensure compliance with appropriate regulatory guidance documents, while driving improvements in product and process quality.

- Support the implementation of the Continuous Improvement program by identifying, leading and implementing improvements.

- Comply with company and Legislative Environment, Health and Safety Requirements.

- Support and execute any other duties as assigned.

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 in designing and implementing quality systems and/or a start-up an advantage.

- Experience in or knowledge of inhalation dosage forms an advantage.

- High proficiency in Microsoft Word/Excel/PowerPoint/MS Project etc.

- Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.

- Good team working and strong communication skills across functions and organization.

- An ability to work flexibly in a changing environment. Good attention to detail and priority management essential.

- Flexibility to learn new skills and take on new tasks and responsibilities.

- The ability to work under pressure to demanding schedules is important, as is the ability to work on one's own initiative.

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

A t Viatris, we offer competitive salar ies , 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.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.

We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

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