Senior QC Systems Technical Specialist

Eisai EMEA; Hatfield; On-site; GBP 50,000 - 70,000; Full time

Benefits offered by this job

Electric charging points for Electric/

Discretionary Bonus

Free onsite parking

Subsidised onsite restaurant and cafe

Learning and development opportunities

Well-being & mental health awareness

Multi-faith prayer room

Job summary

Eisai EMEA is seeking a Senior QC Systems Technical Specialist to provide technical support for laboratory electronic systems (LIMS, CDS) used in the Quality Control Laboratory, ensuring data integrity and GMP compliance.

The role requires a degree in science and at least two years of experience in master data for LIMS/CDS in pharma, plus strong communication and training skills. Hatfield-based, onsite role with a competitive package.

Qualifications

• Degree or equivalent experience in a science discipline.
• 2+ years creating/updating master data for laboratory LIMS and/or CDS in pharma.
• Experience as end user of QC electronic systems; knowledge of GMP and data integrity.

Responsibilities

• Ensure QC laboratory electronic systems comply with SOPs, GMP, data integrity, and Eisai expectations.
• Create, update, and review SOPs and quality policies as required.
• Create or maintain static data for QC electronic systems to ensure GMP-compliant performance.
• Support procurement and qualification of new lab electronic systems.
• Educate and train team members in QC software usage.
• Maintain user access to systems in line with procedures.
• Support change management to keep data available and functioning.

Skills

Communication skills

People management

Data interpretation

Analytical thinking

Education

Degree in science

Tools

LIMS

CDS

Excel

PowerPoint

Word

Job description

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 aSenior 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.

Location: Hatfield, Full time onsite

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 PowerPoint
• 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

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.

We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society.

Our commitment is:

• to embrace and celebrate our differences, respecting and valuing each other.
• to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging.
• to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity

If you have any questions, please contact us on [e-mail]