QA Specialist
3 weeks ago
Vitalograph is a leading manufacturer of medical respiratory diagnostic devices and software, used in the diagnosis of respiratory disorders, and advanced high-reliability equipment and software systems used in respiratory end-point clinical drug trials. We have designed, developed and manufactured respiratory diagnostic devices, software, and consumables for healthcare professionals, for 60 years. Headquartered in the UK, Vitalograph has operations in Ireland, Germany, and the USA.
We are now recruiting for a QA Specialist to join our growing team in Buckingham. With celebrating 60 years in business, expansion plans and growth in the market, now is a fantastic time to join Vitalograph
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.
Requirements:
- 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
What you'll get in return:
- Supportive and dynamic workplace
- See a real world difference in your work by supporting world class Respiratory Clinical Trials
- Excellent company pension scheme
- Death in service benefit of 4 x salary
- Company paid private medical insurance
- Exciting progression opportunities
- Learning & Development initiatives
