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

Eisai Emea; England; On-site; GBP 55,000 - 75,000; 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

Retail discounts

Well-being & mental health programs

Multi-faith prayer room

Job summary

Eisai EMEA is seeking a Senior QC Systems Technical Specialist for a 12-month fixed-term contract. You will provide technical support for laboratory electronic systems (LIMS, CDS) in the QC lab, maintaining master data, analysing issues, and deploying enhancements.

The role requires GMP and data integrity knowledge, plus experience in creating/updating master data for lab systems and strong communication skills to progress projects with internal and external teams.

Qualifications

• 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

Responsibilities

• Ensure Quality Control Laboratory electronic systems used to support the manufacture, packaging and testing of marketed drug products comply with SOPs, GMP and Data Integrity guidelines.
• Create or update SOPs and quality policies related to QC electronic systems.
• Create or maintain static data for QC electronic systems to ensure GMP-compliant performance.
• Support procurement and qualification of new/replacement lab electronic systems.
• Educate and train team members in the use of QC software.
• Ensure user access to systems is maintained per procedures.
• Support change management to keep system data available and functional.

Skills

LIMS

CDS

Data integrity

GMP knowledge

Communication

Lab electronics

Education

Science degree or equivalent

Tools

MS Word

MS Excel

PowerPoint

Job description

Senior QC Systems Technical Specialist - 12 Month Fixed Term Contract (Salaried)(4173)

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
• Retail discounts
• 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.

Eisai EMEA EDI Commitment Statement

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

General Responsibilities (Safety, Quality, Customer, Cost and Innovation)

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