[ref. o9694402] Quality Assurance Auditor
Unilabs York
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 at this exciting period of growth.
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.
Requirements
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.
- 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;
- Ability to work in a team environment;
- Flexible approach to their work;
- Meticulous attention to detail.
Qualifications
The successful candidate will ideally be educated to degree level, preferably in a relevant scientific subject and have a minimum of three years’ experience within GLP/GCP Quality Assurance or at least three 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.
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