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.