At a Glance
- Tasks: Manage documentation and ensure quality standards in respiratory diagnostics.
- Company: Vitalograph, a leader in respiratory diagnostics for over 60 years.
- Benefits: Generous time off, excellent pension, and comprehensive healthcare.
- Other info: Dynamic work environment with opportunities for growth and learning.
- Why this job: Join a team making a real difference in healthcare and clinical research.
- Qualifications: Organisational skills and knowledge of regulations in pharma or devices.
The predicted salary is between 30000 - 40000 £ per year.
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
- Financial Security – Excellent company contributed pension & 4x salary death-in-service benefit
- Comprehensive Healthcare – Company contributed private medical insurance
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 per the study file review schedule and maintain file review trend data.
- Review and administer VIRs.
- Assist the Clinical Trials Archivist with management of the Central Filing room.
- Review documents against applicable regulations, QMS and other study documents, and provide feedback to the Pharma Team for key documents within studies.
- Assist 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.
Q.A. Specialist (UK) in Buckingham employer: Vitalograph Inc
At Vitalograph, we pride ourselves on being an exceptional employer, offering a supportive work culture that values innovation and collaboration in the field of respiratory diagnostics. Our employees enjoy generous time off, comprehensive healthcare benefits, and robust opportunities for professional growth, all while contributing to meaningful advancements in healthcare. Located in the UK, our team is dedicated to making a real difference, ensuring that every member feels valued and empowered in their role.
