• Conduct study, process, and facility audits according to the audit programme and study timelines in accordance with GLP and GCP requirements
• Collaborate with QA and Operational teams across Resolian to enhance quality standards, streamline processes, and drive operational efficiencies.
• Where required, lead the planning and implementation of quality management systems for IVD medical devices.
• Maintain strong and up‑to‑date knowledge of applicable regulations, standards, and industry guidance.
• Provide expert advice and interpretation of regulatory requirements.
• Support the maintenance and continual improvement of Quality Management Systems (QMS).
• Support external inspections, customer audits, and customer enquiries.
• Contribute to the delivery and improvement of training modules.
• Identify, propose, and drive continuous improvement initiatives.
• Support the internal self‑inspection programme.
• Assist with deviation and Quality Incident investigations.
• Participate in external sponsor audits, ensuring feedback is captured and fed into process improvements.
• Build and maintain effective working relationships with suppliers, acting as a key point of contact for external communications

Skills, Education & Qualifications

• Strong knowledge and understanding of working within a GxP regulated environment.
• Experience of working with ISO standards.
• Demonstrable audit skills that can be practicably applied to auditing activities as a sole auditor or as part of a team.
• Experience of establishing audit scope and developing relevant audit schedules and checklists.
• An understanding of the function of the QMS and actively supporting QMS systems such as Deviations, OOS, Change Control and CAPA.
• Able to demonstrate strong customer (internal and external) and regulator interaction skills.
• Experience working within the pharmaceutical industry is preferable.

Qualifications

· Minimum level of BSc in scientific field, recognised auditor certification, or equivalent industry experience.