QA Assistant - Audit
An exciting new opportunity has arisen for an Audit QA Assistant within the medical devices industry. My client is a world-leader in medical diagnostics, specialising in the research, development and manufacture of innovative products focused on Multiple Myeloma, and other immune disorders. My client is expanding rapidly into new territories over the coming years, and is entering a recruitment drive to reflect that market growth. In this role, you will be based in the client’s UK headquarters in state-of-the-art facilities, and your role will include:
• To ensure the Quality Management System (QMS) meets all current Regulatory requirements relevant to our business by carrying out internal audits, acting on any NCRs found and reporting the findings.
• To ensure that our suppliers management system meets all regulatory and business requirements and that supplier qualification, audits and monitoring are appropriate for the products that they supply.
• Management of specific internal audits within the overall program. Ensuring that audits are carried out as planned and that any NCRs are documented and followed up appropriately.
• Advising on appropriate corrective action to take when NCRs are documented and ensuring that any action required is taken within a timely manner. Ensuring that all work undertaken is clearly documented and can be followed by external auditors and regulatory bodies.
• Assisting with external audits and escorting auditors and customers and providing information requested during said audits and inspections. Assisting in the resolution of any NCRs documented during external audits.
• Undertaking audits (both desktop and physical) of key suppliers and reviewing data to contribute to the supplier management program.
• A levels or equivalent in Science
• Auditing experience
• Exposure to con-conformity reporting and CAPA
• Excellent communication skills
• Excellent eye for detail
• Trained Lead Auditor
• Ability to follow processes
• Inquisitive mind