The Company
Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas.
Eisai Manufacturing is the hub of Eisai’s production and supply chain. We make tablets, package these into blisters, label and package vials and bottles. We also manage the wider medicines supply chain and other companies who undertake work on our behalf.
By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.
Your new role
This role is responsible for providing Quality oversight, validation expertise and strategic support for the successful delivery of EML’s facility expansion projects. The role ensures that all qualification and validation activities associated with new facilities, utilities, warehouse operations, and packaging lines are planned and executed in accordance with EML procedures, regulatory expectations, and industry standards.
The job holder will support the development and implementation of validation strategies for the new UK cold‑chain warehouse, new vial packaging line, new auto‑injector packaging line, and associated facility and utility upgrades, ensuring compliance with GMP, GDP, Annex 15, GAMP 5, and EMLs procedures.
The role will provide Quality review and approval of validation documentation, risk assessments, commissioning and qualification deliverables, and ensure that systems, equipment and facilities are introduced in a compliant and controlled manner.
It will also contribute to the creation, review and maintenance of validation‑related policies, procedures and templates to ensure they remain aligned with current regulatory and project requirements.
The job holder will act as a Quality Subject Matter Expert (SME) for qualification, validation, and CSV within the scope of the facility expansion projects, ensuring the application of data integrity principles and supporting successful project execution from design through to handover and operational readiness.
**This is a 1yr salaried fixed term contract