Viatris

Documentation Administrator

Posted 8 Days Ago

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Inverin, Galway

1-3 Years Experience

Healthtech • Biotech • Pharmaceutical

The Role

The Production Documentation Administrator at Viatris is responsible for providing document support services to the Production Department. Duties include updating forms and procedures, coordinating document sign-offs, generating change control requests, controlling documentation flow, and ensuring compliance with quality standards and GMP practices. The role also involves investigating quality incidents and providing support across the quality function as needed.

Summary Generated by Built In

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 Production Documentation Assistant is responsible for document support services to the Production Department.

Every day, we rise to the challenge to make a difference and here’s how the Production Documentation Administrator role will make an impact:

Update forms and procedures as appropriate, working closely with other members of the Production Department.
Coordinate sign-off of procedural documentation.
Update Training assessments as required.
Generate Change Control Requests as directed by Senior Production personnel.
Control the flow of documentation within production with responsibility for generating, authoring and reviewing cGMP documentation on EDMS (Documentum).
Produce reports/metrics as required.Investigated quality incidents to identify root causes and implemented corrective and preventive actions (CAPAs) to prevent recurrence.
Work to company quality standards and GMP to ensure that a quality product is released to customers at all times.
Provide support across the quality function as required; be flexible in approach to work in order to meet business needs.
Perform other duties as assigned, this includes supporting the Packaging Dept. in Casla when required.

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:

A minimum of a leaving certificate (or equivalent) with a minimum of 1 years’ experience in an administration or documentation role within a medical device/ pharmaceutical company.
Knowledge of FDA and ISO regulations and GMP practices.
Experience of EDMS (Documentum) and Trackwise a distinct advantage.
Excellent verbal, literacy and numerical skills.
Must have excellent organizational (Time Management) skills, attention to detail and computer skills including Excel, Word and Lotus notes.
Be able to work independently as well as a flexible member of a team in a dynamic fast paced environment.

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.