At a Glance
- Tasks: Conduct audits and enhance quality standards in a dynamic environment.
- Company: Join a leading pharmaceutical company focused on quality and innovation.
- Benefits: Competitive salary, professional development, and opportunities for growth.
- Other info: Collaborative culture with strong focus on continuous improvement.
- Why this job: Make a real impact on quality assurance in the pharmaceutical industry.
- Qualifications: BSc in a scientific field and experience in GCP/GLP environments.
The predicted salary is between 45000 - 55000 £ per year.
- 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.
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Senior QA Advisor employer: Resolian
Resolian in Fordham is an exceptional employer that prioritises employee development and fosters a collaborative work culture. With a focus on quality assurance and innovation in the pharmaceutical sector, employees benefit from hands-on experience with cutting-edge analytical techniques and opportunities for professional growth in a supportive environment.
We think you need these skills to ace Senior QA Advisor
GCP Knowledge
GLP Knowledge
Audit Skills
Quality Management Systems (QMS)
Regulatory Compliance
Continuous Improvement Initiatives
Deviation Management
