Job Description

As Quality Assurance Auditor, you’ll be responsible preparing, managing and maintaining all quality documentation systems. You’ll verify that study documentation contains the information required for compliance to the principles of Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP).

Key Accountabilities;

• Maintain copies of all approved study documents and standard operating procedures in use.
• On a regular basis provide progress updates on all aspects of the quality system.
• Conduct inspections to determine if all studies are conducted in accordance with GLP or GMP and report any findings to management.
• Audit final reports to confirm that the methods, procedures and observations are accurately and completely described, and that the reported results are a true reflection of the raw data. To promptly report any raw data inspection results to the Study Director / Scientist and any Principal Investigator and the respective management when applicable.
• Prepare and sign a statement in the final report that accurately details inspections that have been performed and confirm that the raw data reflects the raw data of the study.
• Providing compliance advice and guidance to staff as required and providing support for Study Directors in troubleshooting problems and in discussing projects with clients.
• To interact with clients in the audit process. To provide clients with regular updates on the progress of their reports or corrective and preventative actions, when required.
• To interact with clients with respect to any deviations, investigations and out of specifications and to ensure that any corrective and preventative actions (CAPAs) that arise from these are completed appropriately.
• To be involved in with the compliance and quality aspects of any deviations, corrective actions and investigations.
• To support, assist in the management and reporting of any deviations, corrective actions and investigations to the management of SGS.

Required Knowledge, Skills, and Abilities

To be successful in this role, you’ll need previous QA auditing experience within a highly regulated environment. You’ll demonstrate excellent attention to detail and good auditing practices and will have lots of experience in the use of databases for management of information. Good IT skills, experience in word, excel, PowerPoint. Familiarity with working to business and regulatory guidelines. Good communication skills. Good analytical reasoning / mathematical skills. Educated to Degree level. GLP/GMP / regulatory background. Auditing experience. Regulatory knowledge. Degree level in Biological Science preferable. Quality Assurance qualification.