Highly organised and reliable professional with expertise in quality systems, business analysis, data analysis, and process development. Demonstrates strong interpersonal skills and critical thinking to effectively manage workflows, scope projects, and conduct cost-benefit analyses. A keen eye for quality and commitment to excellence. Demonstrates strong analytical skills and leadership capabilities, ensuring seamless project execution and team collaboration. Committed to elevating standards and enhancing operational efficiency.
- Co-ordinated the weekly Change Control Board and papers, appraising submissions and providing feedback to services. I raised all change requests in the electronic quality management system as well as playing a key role in the Change control continuous improvement process.
- Acted as subject matter specialist on a process improvement change controls project, defining the scope of change, what activity needed a change control and how this would be managed.
- Helped set requirements and support the multi stage project implementation of a new Electronic quality management system for the company.
- Acted as project manager on an external quality project. I rescoped the original project which had paused and took it back to first principles to better align it to the company's needs. Personally designed new metrics and dashboards.
- Undertook inspection readiness work, reviewing post inspection action logs including ones from previous MHRA GMDP audits and planning to review progress, address risks and issues and prepare documents for inspection.
- Experience of leading an internal inspection into an artwork deviation issue conducting an impact assessment, 7 root cause analysis, and the raising of subsequent corrective and preventative actions.
- Undertook audit training and experience, undertaking extensive training with certified auditors. I was involved in a virtual inspection of a pharmaceutical contract research organisation looking at their facilities and QMS.
Shadowed multiple departments, regulatory, quality, data insights and project areas.