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Job Post Details

QA Specialist - job post

Vitalograph
3.1 out of 5 stars
Vitalograph Business Park, Buckingham MK18 1SW
Permanent
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Job details

Job type

  • Permanent

Location

Vitalograph Business Park, Buckingham MK18 1SW

Benefits

Pulled from the full job description

  • Annual leave
  • Company pension
  • Private medical insurance

Full 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

IND1

Work Location: In person

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