Description
QA Auditor - 6 months FTC (Fixed term contract)A major Biotechnology/Pharmaceutical organisation based on the Cambridgeshire/Suffolk border has a fantastic opportunity for a temporary QA Auditor to join the team. The QA Auditor works to maintain and manage the sites third party quality audit system. Other duties include co-coordinating the performance of inspections and external audits to assure compliance with applicable regulations.
The Role:
.Manages a risk based approach to supplier assessment and approval
.Leads external audit/inspections of suppliers of goods and services including computerised systems
.Agrees corrective and preventive actions with audited suppliers of goods and services
.Follows up on the progress and implementation of corrective and preventive actions.
.Maintains an awareness of suppliers quality performance
.Acts as Regulatory Intelligence contact for site
.Maintaining a good knowledge of Good Manufacturing Practice
.Acts as the QA point of contact for any 21 CFR Part 11 and computer system quality issues
.Co-ordinates the provision of the backroom for all external and regulatory audits/inspections
.Co-ordinates the responses to all external and regulatory inspections including corporate audits
.Provides advice and support to managers and resolve routine and some non-routine compliance and regulatory issues
.Manages relevant systems and databases in relation to audits/inspection
.May participate in performing site internal quality audits
Experience:
.A science/engineering graduate or equivalent
.Qualified lead auditor ideally
.Demonstrate a commitment to quality
.Computer-literate, with experience in the use of MS Word, Excel and Powerpoint
.Proven ability to lead external audit/inspections of suppliers of goods and services including computerised systems successfully
.Demonstrated knowledge of working within a quality management system and cGMP
.Has detailed up to date regulatory knowledge
.Possess an excellent understanding of cGMP
.Keeps up to date with relevant regulations and legislation
A fantastic salary is on offer alongside an exceptional opportunity to join a major Biotechnology/pharmaceutical organisation.
Please apply today with covering letter highlighting your key skills and relevant experience aligned to this opportunity.