Want to work for a £100 million + turnover, Private Equity backed, fast growing and dynamic global business that has doubled its revenues in the last five years with a firm strategy to double them again in the next 5 years?
We are a unique company with a unique product in a unique environment that is a great place to work but don’t just take our word for it…please see our unsponsored Glassdoor reviews
We have a great opportunity for an Audit Team Manager (Quality Systems) to lead the Audit team and to develop a quality programme for our key external suppliers and to create and embed in manufacturing the importance and business benefits of internal audits
Quality System Specialist - Audit Team Manager
• Responsible for management of the internal and external audit process. Ensure all QMS and regulatory requirements are met within this process.
• To be responsible for planning and scheduling annual internal audit schedule.
• Ensure all audits are carried out as scheduled.
• To carry out periodic internal audits as a Lead Auditor. Raising NCR and CAPA where appropriate.
• To be responsible for planning and scheduling annual supplier audit schedule
• To carry out periodic off site supplier audits
• Responsible for line management of audit team. Including team and individual development programs.
• Work with internal customers to help facilitate remedial actions
• To represent the company at external regulatory and customer audits.
Principal Duties and Responsibilities.
• Company Auditor. Responsible for Internal Audits. This includes being trained to be able to:
• Creation of annual compliance plan
• Creation of Audits on IFS. Selection of appropriate auditors.
• Creation of audit plans
• To carry out periodic audits as a lead auditor. To be able to highlight non conformance
• To write an audit report and add to ERP audit
• To be able to complete and close audits on ERP system
• Responsibility for creation of NCR, scoring and CAPA for internal audits and following NCRs up.
• Able to produce audit reports for circulation after audit, and final report after audit closed
• To be able to deliver IFS System Training for Audits.
• To be able to produce QSRM reports when required.
Knowledge and Skills
•Experience of working within a manufacturing environment or previous QA experience
•Has led several internal audits.
•Has participated in regulatory audits.
•Good computer skills, Microsoft Office and Database experience
•Able to manage multiple projects, good problem solving skills, good attention to detail, ability to communicate with all levels of staff,
•Decision making based on evidence
•NCR and CAPA experience
•Knowledge of the application of quality systems in manufacturing
•Knowledge of ISO and FDA Quality System Regulations.
- External Audit
- Internal Audit
- Quality System
- Audit Reports
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