Senior QC Systems Technical Specialist

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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

As a Senior QC Systems Technical Specialist, this job is responsible for providing technical support for all laboratory electronic systems (e.g. LIMS, CDS) used within the Quality Control Laboratory. This includes master data maintenance, providing technical support to understand and resolve issues and implement agreed solutions and supporting future enhancements (e.g. the deployment of new modules, software updates).
The role must:

• Ensure Quality Control Laboratory electronic systems used to support the manufacture, packaging and testing of marketed drug products comply with department Standard Operating Procedures, current GMP, Data Integrity guidelines and Eisai Corporate expectations.
• Provide input in the creation, update and review of any associated SOPs and quality policies, as required.
• Create or maintain new static data for QC electronic systems to ensure performance in line with EML procedures and GMP guidelines for electronic systems.
• Support the procurement and qualification of new/replacement lab electronic systems as required.
• Support the education and training of team members in the use of specialist QC software as required.
• Ensure user access to systems are maintained in line with procedures
• Support change management process to ensure system data is continuously available and functioning as intended.

What are we looking for?

• Degree or equivalent experience in a science discipline.
• Strong working knowledge of pharmaceutical Quality Control electronic systems, including their qualification and validation.
• Significant previous experience (at least two years) in creating/updating master data for a laboratory LIMS and/or CDS system, within the pharmaceutical industry.
• Experienced as an end user of QC electronic systems.
• Excellent communication and good people management skills to support progression of technically led projects internally and externally.
• Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
• Ability to understand and analyse user requirements to facilitate changes and system improvements
• Good understanding of the requirements of data integrity and application to system management
• Good technical and scientific judgement
• Ability to interpret complex data and present key findings
• Ability to describe technical information in easy-to-understand terms.
• Computer literate e.g. Word, Excel and Power Point
• Thorough understanding of GMP Guidelines and Regulations
• Maintain knowledge and understanding of technical advancements in electronic systems

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package that includes,

• Electric charging points for Electric/Hybrid vehicles
• Discretionary Bonus
• Free onsite parking
• Subsidised onsite restaurant and coffee shop
• Learning and development opportunities
• Well-being & mental health awareness programmes
• Multi-faith prayer room
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