Document Control Coordinator

Recruiter
Viatris
Employment Type
Permanent
Salary
Not disclosed
Viatris logo

1484 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 Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.

Every day, we rise to the challenge to make a difference and here’s how the Document Control Coordinator role will make an impact:

Key responsibilities for this role include:

  • Provide support to execution of activities in the GDD Document Management Systems including but not limited to:
  • Execution of Document Coordinator activities in the GDD Document Management Systems through the review and release of new and modified documentation in Documentum.
  • Ensuring Good Documentation Practices are communicated clearly in the organisation, understood and adhered to.
  • Providing SME technical support on the document management system to the GDD Team.
  • Assignment of document numbers and resolution of questions and issues raised by Document Originators and Approvers.
  • Supporting the implementation of upgrades to the GDD Document management system.
  • Supporting the ongoing continuous improvement of Document Control processes / procedures in accordance with department and company goals.
  • Maintain the GDD Document Log, ensuring it is up-to-date and reflective of the current documentation status.
  • Coordinate control of documents of external origin.
  • Coordinate the removal and archiving of documents and records in line with Global Viatris and local GDD policies and procedures.
  • Support management of Training in GDD as it relates to induction / on-boarding and delivery of refresher training as required, the maintenance of the training management system (MyUni) and monitoring of the training process.
  • Support ongoing monitoring of GDD Quality Objectives and generate data for input to monthly objectives reports and into Management Review.
  • Support the general development and improvement of the GDD Quality System through participation in and/or management of CAPA, Internal Audit program, complaints, trending and training
  • Support third party inspections/audits

The minimum qualifications for this role are:

  • Third Level Degree or equivalent or a combination of education and training and direct transferrable experience
  • Qualification in delivery of training, such as the Train the Trainer certification desirable, but not essential.
  • Minimum 3-5 years relevant professional experience
  • Demonstrated ability to perform in a high performing workforce
  • Demonstrated understanding of Quality Management System requirements e.g. ISO13485, 21 CFR 820 as they relate to the principals of Document and Record Control.
  • Demonstrable experience with Document and Record Control practices, Data Integrity and Good Documentation Practices.
  • Demonstrable experience in the delivery of training (Induction and Refresher) in the use of document management systems such as Documentum.
  • Experience coordinating delivery of read and understand training on SOPs and Documents through Training Management Systems such as MyUni.

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.
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