Senior QC Systems Lead – LIMS/CDS Expert (12-Month)

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

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.