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
The Quality Operations Associate will support EML (Eisai Manufacturing) Quality Systems and Assurance activities for the manufacture, packaging, testing, storage and distribution of EML and third-party contract manufactured drug products, ensuring compliance with current GMP, Eisai Quality Systems, Eisai Corporate expectations and Industry Standards Support the review and writing of quality policies, systems and procedures as required.
Support the effective implementation, by all stakeholders, of aspects of the operational Quality Management System (QMS), including, but not limited to, Product Quality Reviews, Quality Agreements, Parallel Imports, Change Control, Risk Management, Deviations/Incidents, Training, Documentation, Internal and External Audits, Approved Supplier Systems and use of the TrackWise eQMS within Eisai Manufacturing Limited.
What are we looking for?
- Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
- Basic knowledge of Quality Systems, Quality Assurance, GMP and basic understanding of manufacture and packaging of pharmaceutical products
- Good technical and scientific judgement
- Ability to interpret complex data and present key findings
- Computer literate e.g. Word, Excel and PowerPoint
- Basic understanding of GMP Guidelines and Regulations