Quality Auditor - Nottingham

Quality Auditor

We are currently seeking a Quality Auditor to join the team at RenaSci in Nottingham.

The enthusiastic individual we seek will have a relevant life science or quality management qualification combined with laboratory-based research experience within the CRO, pharmaceutical or biotechnology sector. Experience in QA is essential and a working knowledge of Good Laboratory Practice is required.

The successful candidate must be capable of informed decision making and whilst working independently have a proactive approach to regulatory compliance.

Duties and responsibilities will include:

• Schedule and carry out in-life inspections of the drug abuse studies to ensure compliance with GLP requirements
• Work in accordance with all study plans and amendments in accordance with the regulatory standards
• Conduct data and report audits in accordance with the regulatory standards
• Ensure the maintenance of the QA schedule and systems and comply with the company standard operating procedures
• Work effectively with Study Directors and Project Managers to schedule inspections and monitor the follow up actions
• Proactively keep up to date with all relevant regulatory authority requirements (MHRA, OECD, FDA)
• Represent Renasci regarding QA as required in relation to audits, inspections and all other compliance-based activities
• Perform any other regulatory compliance duties as may be required from time to time by the Test Facility Management

Skills and experience required for this role

• Life Science graduate and/or equivalent quality management qualification / certification
• Experience in a laboratory environment operating under GLP is essential
• Able to deliver deadlines under pressure
• Proficient in Microsoft Office
• Diplomatic, polite and professional
• Contribute positively to the team
• Organised with excellent attention to detail
• Enthusiastic and Self-motivated

Please send your CV to Jean Smith by clicking on the 'Apply' button.