Description
QA Auditor (Supplier/ External Audit) - PermanentA major Biotechnology / Pharmaceutical organisation based on the Cambridgeshire/Suffolk border has a fantastic opportunity for a QA Auditor to join the team. The role will involve maintaining and managing the site third party quality audit system. You will co-ordinate 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
*Lead external audit/inspections of suppliers of goods and services including computerised systems as required
*Agrees corrective and preventive actions with audited suppliers of goods and services
*Follows up on the progress and implementation of corrective and preventive actions
*Makes recommendations about continued use of suppliers with marginal compliance based on risk
*Maintains an awareness of suppliers quality performance
*Acts as Regulatory Intelligence contact for site
*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
*Fully supports business process improvement and continuous improvement
*Develops and maintains metrics for monitoring performance of the site Quality Management System, as required
*May participate in performing site internal quality audits
Experience
*A science/ engineering graduate or equivalent
*Ideally a Qualified lead auditor
*Has an excellent understanding of cGMP
*Good knowledge of Good Manufacturing Practice, current legislation and regulations
*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
*Can demonstrate a commitment to quality
*Good influencing and negotiating skills to ensure implementation of appropriate corrective/ preventive actions
A fantastic salary and benefits package 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.