Tom Bell

Working across multiple aseptic manufacturing facilities providing QA expertise and independent assurance of quality standards to support the timely resolution of product quality issues.

Providing GMP expertise to production through training and awareness initiatives to operators, working directly with plant management and other key stakeholders on continual improvement; influencing complete documentation and correction of all deviations through effective problem solving and timely and resolution of any CAPA with a focus on inspection readiness.

Experienced in deviation, CAPA, change control, SOP and batch document approval.

Providing product release decisions, considering regulatory dependant market restrictions on a variety of different drug variants within global markets.

Specialist in clean room behaviour and leading culture change through transparency in aseptic observations documentation and reporting.

Based within sterile manufacturing, responsible for batch document review. Ensuring correct and sufficient environmental monitoring has been completed for every batch produced through review of physical, particle and microbiological data also approving cleaning records.

An experienced deviation manager responsible for implementing effective corrective and preventative actions.

Performing regular sterile observations and process confirmations to confirm adherence to SOPs.

Responsible for the investigation of external product quality complaints.

Championing good aseptic behaviours and leading initiatives to highlight and improve trends in negative behaviour.

Providing training in GMP and ALCOA+ principles to all manufacturing teams and being an approachable member of QA who is visible on the ground integrated within production.

Coordinated the Microbiology team during weekends and bank holidays.
Deviation manager.
Working knowledge of Level 0 and HERCA problem solving tools.
Provide technical advice to operators, technicians and other faculty members regarding personnel and environmental monitoring.
Trained in MODA.

Working within the Process Assurance Team (PAT), I have gained in depth experience of Environmental Monitoring and have obtained my Aseptic Licence.

I strived for continual improvement, and constantly look for routes of method streamlining and simplification, with a focus on overall standardisation.
Held the RMA licence for PAT and was responsible for archiving within the team.
Familiar with the production of Operational Qualification Programmes for Temperature Controlled Rooms.

Implementing and improving updated quality assurance systems between many departments. Performing daily GMP audits, ensuring safety and quality standards are achieved and maintained across two manufacturing facilities. Developing procedures and documenting training.