Quality Assurance Auditor
Unilabs · York · £38,000–£48,000 (stated in the posting)
About Unilabs
Headquartered in Geneva and part of the A.P. Moller Group, Unilabs is one of Europe’s leading medical diagnostics companies, offering a complete range of laboratory, pathology, genetics, and imaging services to patients across 14 countries. Unilabs invests heavily in technology, equipment, and people – using digital technologies in its state-of-the-art laboratories and imaging institutes – to improve the lives of close to 100 million people every year.
About the Role
As the premier, independent, UK-based provider of bioanalytical services to the world's pharmaceutical industry, we have strong ideas about the value of our staff in providing a top quality, scientific service to our clients. An opportunity has arisen for a Quality Assurance Auditor to join the company.
The Quality Assurance Auditor will work closely with other members of the Quality team and will be responsible for the independent monitoring of work to ensure compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), as required.
We require a Quality Assurance Auditor, reporting to the Head of Quality Assurance, the Auditor will be responsible for:
- Reviewing study plan/phase plans for compliance with GLP and GCP where required
- Conducting data, data transfer file and report audits
- Writing up findings of quality assurance audits and inspections
- Reporting of all quality assurance audit and inspection findings to management and the responsible person
- Advising of Management of any deficiencies in regulatory requirements
- Performing administrative tasks as required
- Scheduling and conducting procedural audits
- Conducting facility inspections
- Conducting computer system validation audits
- Reviewing equipment qualification protocols, data and reports
Skills / Experience:
- Previous experience of working within a similar role in a GLP/GCP compliant environment
- Understanding and knowledge of GLP & GCP quality assurance requirements
- Capability to perform independent audits
- Good verbal and written communication skills
- Practical knowledge of carrying out GLP/GCP audits
- General awareness of industry quality systems/ standards and regulattions
- Ability to work in a team environment
- Flexible approach to their work
- Meticulous attention to detail
Requirements
- The successful candidate will be educated to degree level, preferably in a relevant scientific subject
- Have a minimum of five years’ experience within GLP/GCP Quality Assurance or at least five years’ experience within a GLP/GCP environment or equivalent experience working within an organisation supported by a quality management system.
- Experience in the field of bioanalysis would be considered highly advantageous.
Benefits
- Salary £38-48k dependent upon experience and relevant qualifications
- Company Pension Scheme
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