Quality Systems Specialist Learning Management System (12 months secondment)

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 Learning Management System (LMS) (12 Month Fixed Term) role will make an impact:

• Site lead for learning management system, MyUniversity, as site administrator ensuring all content is approved and current (in line with D2 content).

• Responsible for maintaining system compliance; ensuring all user learning plans, curricula content are up to date, credited contemporaneously. 

• Responsible for GMP, GDP, ISO13485 training compliance; keeping all training SOP, WI updated in line with global, local policies.

• Site Training lead for all internal audits, health authority inspections.

• Responsible for site training related quality management system investigations, and associated CAPA’s (including TrackWise management).

• Responsible for delivering and monitoring all training metrics; weekly, monthly, quarterly and annually. Requires proficiency in Excel, knowledge of BI, other analytical tools.

• Proactively communicates effectively with all stakeholders to review and improve training metrics.

• Coordinates Dublin Respiratory training plan, internal and external training logistics, including training service providers, AVL management.

• Provide QA support to site to ensure Inspection Readiness.

• 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, including but not limited to;

• GMP, Induction training, support/develop and implement site Quality Systems to include SOPs, document control, change control, investigations, CAPA, internal auditing, vendor qualification & management, material and batch disposition, complaints and annual product review

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 3+ years industry experience or equivalent.

• 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

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.