Quality Assurance Auditor

Unilabs; York and North Yorkshire; Presencial; GBP 38 000 - 48 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Company Pension Scheme

Resumo da oferta

Unilabs is recruiting a Quality Assurance Auditor to join the UK-based quality team and independently monitor work for GLP and GCP compliance. The role reports to the Head of Quality Assurance and conducts audits of study plans, data, reports, facilities, and computer systems while communicating findings to management.

Applicants should have a degree in a scientific subject and at least five years' GLP/GCP QA experience, with strong attention to detail and teamwork in a regulated environment.

Qualificações

• Experience in GLP/GCP environments and quality systems.
• Ability to perform audits and identify regulatory deficiencies.
• Good written and verbal communication skills.
• Familiar with industry quality standards and regulations.

Responsabilidades

• Review study plans for GLP/GCP compliance.
• Conduct data, file and report audits.
• Write audit findings and report to management.
• Advise management on regulatory deficiencies and improvements.
• Perform facility, computer system validation, and equipment qualification audits.
• Schedule and conduct procedural audits and inspections.

Conhecimentos

GLP/GCP knowledge

Audit execution

Quality assurance

Verbal and written communication

Attention to detail

Teamwork

Flexibility

Independent auditing

Formação académica

Degree in a relevant scientific subject

Descrição da oferta de emprego

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 auditsGood 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

• 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.

• Salary £38-48k dependent upon experience and relevant qualifications
• Company Pension Scheme

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