CY Partners Recruitment is delighted to be partnering with growing Biotechnology company based in Newcastle with their search for a Quality Assurance/Regulatory Affairs (QARA) Officer.  

Reporting to the QARA Manager in this key role you will ensure compliance with quality standards, regulatory requirements and best practice within the organisation.

This is an exceptional role for someone who is looking to take a step into a dynamic environment, with projected significant growth for the organisation and the post-holder.  

Main Duties and Responsibilities

-              Document Control – responsible for the document control system ensuring accurate and up to date records of procedures and quality related documents.

-              Corrective and Preventative Actions (CAPA) – overseeing the CAPA process which involves identifying and addressing issues, deviations and non-conformities to improve product quality and compliance.

-              Change Management – coordinating changes to processes, products or systems while maintaining quality standards.

-              Technical Files – working with the quality team to create and update product technical files.

-              Develop, implement, and manage quality systems designed to ensure continuous production/service that meets established standards and customer specifications.

-              Perform routine inspections to verify compliance with company and regulatory requirements.

-              Analyse data to identify areas for improvement in the quality system including troubleshooting product or process failures.

-              Coordinate with operations and development teams to ensure quality standards are understood and integrated in all areas.

-              Facilitate corrective actions and improvement strategies for non-conformances and quality issues identified during internal and external audits

-              Lead training sessions for staff on quality assurance processes, tools and standards to foster a quality-centric culture within the organisation.

-              Support the internal audit process and preparation for notified body audits.

-              Follow company quality procedures and promote quality practises within the organisation.

-              Support update of QMS for IVDR

-              Be proactive and show initiative regarding time management, work prioritisation and committing to time-critical tasks

-              Work cross functionally with other teams and functions across the business

-              Involvement in risk management

To be considered for the role of QA/RA Officer, you’ll need the following qualifications, skills and experience:

-             Bachelor’s degree or equivalent experience in a Life Science subject.

-             Experience in quality assurance and regulatory affairs within the medical device, pharmaceutical or related industry.

-              Possess a knowledge and understanding of Quality Management Systems (QMS) and standards and regulations according to ISO 13485 and IVDR or similar.

-              Knowledge of NC/CAPA investigations.

-              Excellent attention to detail regarding existing and new documentation.

-              Experience or knowledge of IVD medical devices and Quality Systems.

-              Positive, team-focused approach to working and problem-solving.

-              Competent with Microsoft Word, Excel, PowerPoint and SharePoint.

Location – The role is to be primarily based at the site in the Newcastle upon Tyne.

Application Instructions:

Please apply online here - 

CY Partners is acting as an Employment Business / Agency in relation to this vacancy