At a Glance
- Tasks: Conduct audits and enhance quality standards in a dynamic environment.
- Company: Resolian, a leader in quality assurance within the pharmaceutical industry.
- Benefits: Competitive salary, professional development, and a collaborative team culture.
- Other info: Join a supportive team with opportunities for career growth and development.
- Why this job: Make a real impact on quality processes and drive improvements in the industry.
- Qualifications: BSc in a scientific field and experience in GCP/GLP environments.
The predicted salary is between 40000 - 50000 £ per year.
- Location & Employee Type
- Location Newmarket Road, Fordham, CB75WW, United Kingdom
- Employee Type FT Exempt
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.
Requirements
Experience
- 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.
Summary
The (Senior) QA Advisor plays a pivotal role in partnering with operational teams across Resolian to strengthen quality standards, drive process improvements, and enhance organisational efficiency.
Key responsibilities include conducting study audits and process inspections to ensure compliance with GLP and GCP regulations, while supporting continuous improvement initiatives across the business.
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