At a Glance
- Tasks: Manage documentation control and support quality audits in a dynamic environment.
- Company: Join a leading company in the pharmaceutical industry focused on quality assurance.
- Benefits: Gain valuable experience, competitive salary, and opportunities for professional growth.
- Other info: Collaborative team atmosphere with opportunities for career advancement.
- Why this job: Make a difference in clinical trials while developing your skills in quality assurance.
- Qualifications: Strong organisational skills and familiarity with ICH GCP regulations preferred.
The predicted salary is between 30000 - 40000 £ per year.
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.
Q.A. Specialist (UK) in Buckingham employer: Vitalograph
As a Q.A. Specialist at our company, you will thrive in a supportive and collaborative work environment that prioritises employee growth and development. We offer comprehensive training programmes, opportunities for career advancement, and a culture that values quality and compliance, all set in a dynamic location that fosters innovation and teamwork. Join us to be part of a dedicated team committed to excellence in the pharmaceutical industry, where your contributions will make a meaningful impact.
We think you need these skills to ace Q.A. Specialist (UK) in Buckingham
Documentation Control
Change Control Management
SmartSolve Administration
Controlled Document Maintenance
Study File Review
VIR Review and Administration
Regulatory Compliance Review
