About Us
For over 60 years, Vitalograph has been at the forefront of respiratory diagnostics, developing cutting-edge medical devices and software used worldwide. With operations in the UK, Ireland, Germany, and the USA, we’re committed to making a real difference in healthcare and clinical research.
Here’s what you can look forward to:
- Generous Time Off – 23 days of annual leave to recharge and unwind
- Financial Security – Excellent company contributed pension & 4x salary death-in-service benefit
- Comprehensive Healthcare – Company contributed private medical insurance for your well-being
Responsibilities:
- Documentation Control to include, issuing new documentation, managing change control and maintenance of tracking spreadsheets.
- Ensure QA tracking spreadsheets are kept up to date.
- SmartSolve administration of training, document control and user profiles. Maintain list of controlled documents, including biennial review dates and status.
- Perform study file reviews as per the study file review schedule and maintain file review trend data
- Review and administration of VIRs.
- Assist the Clinical Trials Archivist with management of the Central Filing room.
- Reviewing documents against applicable regulations, QMS and other study documents, and providing feedback to the Pharma Team for key documents within studies.
- Assisting with problem solving issues
- Perform Internal Quality Audits as required by QA Supervisor
- Support successful external quality audits as required by QA Supervisor.
- Other reasonable tasks as requested by the Quality Assurance Supervisor, or Vitalograph Management.
Outline of skills required:
- Computer literacy e.g. MS Word, Excel PowerPoint and Visio.
- Demonstrated organizational skills
- Working knowledge of ICH GCP and appropriate regulations*
- Experience of audits in pharma or devices arena preferable.
- Experience in administrative tasks in document management an advantage
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Work Location: Remote
