- 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.