Senior QA Advisor

Responsibilities

• 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.
• 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 by performing process and facility audits.
• 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 GCP/GLP regulated environment.
• Demonstrable audit skills that can be practically 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, Change Control and CAPA.
• Able to demonstrate strong customer (internal and external) and regulator interaction skills.
• Experience working within the pharmaceutical industry is preferable.
• Previous experience working in a bioanalytical laboratory is preferable but not essential.

Qualifications

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