Senior QC Systems Technical Specialist - 12 Month Fixed Term Contract (Salaried)

Consortium; Hatfield; On-site; GBP 45,000 - 65,000; 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 seeks a Senior QC Systems Technical Specialist based at the EMEA Knowledge Centre in Hatfield to provide technical support for laboratory electronic systems (LIMS, CDS) in the Quality Control Laboratory, including master data maintenance and issue resolution.

You will contribute to SOP development, data integrity, and future enhancements, ensuring GMP compliance and data accuracy while collaborating across QC and manufacturing teams.

Qualifications

• Degree in science discipline.
• Strong knowledge of QC electronic systems incl. qualification/validation.
• 2+ years in master data for LIMS/CDS in pharma.
• End-user experience with QC electronic systems.
• Excellent communication and people management.
• Ability to interpret data and present findings.
• Good understanding of GMP guidelines and regulatory expectations.

Responsibilities

• Ensure QC laboratory electronic systems (LIMS/CDS) comply with SOPs and GMP.
• Provide input for SOPs and quality policies as required.
• Create or maintain static data for QC systems per GMP/EML procedures.
• Support procurement/qualification of new lab electronic systems.
• Educate/train team members in QC software usage.
• Maintain user access per procedures.
• Support change management to keep data available and accurate.

Skills

GMP compliance

Data integrity practices

LIMS/CDS experience

Communication skills

Stakeholder management

Education

Degree in science

Tools

LIMS/CDS systems

Job description

Senior QC Systems Technical Specialist - 12 Month Fixed Term Contract (Salaried)

Senior QC Systems Technical Specialist - 12 Month Fixed Term Contract (Salaried)

Location: Mosquito Way, Hatfield AL10 9SN, UK

Highlighted points for this job

Senior QC Systems Technical Specialist role

Competitive salary and benefits package

Location based at EMEA Knowledge Centre

Responsibilities include compliance with GMP and data integrity

Requirements include degree in science and 2+ years LIMS experience

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 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

To ensure that operations conducted are performed in accordance with the requirements of Eisai Corporate Standards, Eisai Quality Systems, GMP and GDP Guidelines and Industry Standards.

Duties are performed to ensure:

• A safe working environment is maintained for self and other Eisai employees, ensuring all near miss incidents and accidents are reported in accordance with procedures
• The Quality of products manufactured and released is assured through adherence to all procedures
• Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives
• Eisai’s philosophy of hhc is at the forefront of daily activities
• All stakeholder and customer expectations are understood and met through communication.
• Performance is in line with personal and Eisai objectives with demonstrated behaviours and competencies