Posted: 18 June
The role
Job Description
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
