Onsite Quality Control Analyst - GMP/QA Expert

Eisai Inc.; Hatfield; Hybrid; GBP 28,000 - 35,000; Full time

Job summary

Eisai Europe Limited in Hatfield is seeking a Quality Control Analyst for a permanent, full-time role on site. The position requires testing materials to spec, calibration of equipment, and maintaining quality systems in line with GMP and GDP standards.

You will contribute to audits, CAPAs, and deviations investigations while supporting technical transfers and change controls. The role emphasises collaboration with the Quality, regulatory, and manufacturing teams, ensuring timely release of

Qualifications

• Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers.
• Extensive knowledge of Quality Control, Quality Assurance, Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products.
• Good technical and scientific judgement.
• Ability to interpret complex data and present key findings.
• Computer literate e.g. Word, Excel and PowerPoint.
• Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations.
• Diplomatic, self-motivating.
• Problem solving and decision-making capabilities.
• Professional behavior and self-awareness.
• Ability to work effectively within a Team.

Responsibilities

• To test all materials according to agreed specifications and procedures.
• To maintain and calibrate all laboratory equipment according to approved procedures.
• To maintain all laboratory Quality Systems and Quality Management Systems in compliance according to approved procedures.
• To write under supervision, all SOPs associated with QC support.
• To support the internal and external audit process and audit schedules as appropriate.
• To support the preparation and hosting of competent authority inspections.
• To raise and support the investigation of deviations and associated CAPA’s.
• To support technology transfer projects and in particular any QC aspects of these.
• To support the implementation of change control activities.
• To support the process for data collection for PQR’s.
• To support the collection of data for reporting Quality Assurance Performance Indicators.
• To support the implementation and management of stability programmes.
• To perform any other appropriate duties at the request of the QC Head.

Skills

Quality Control

Quality Assurance

GMP Regulations

Data interpretation

Analytical mindset

Communication

Teamwork

Tools

Word

Excel

PowerPoint

Job description

Eisai Europe Limited in Hatfield is seeking a Quality Control Analyst for a permanent, full-time role on site. The position requires testing materials to spec, calibration of equipment, and maintaining quality systems in line with GMP and GDP standards.

You will contribute to audits, CAPAs, and deviations investigations while supporting technical transfers and change controls. The role emphasises collaboration with the Quality, regulatory, and manufacturing teams, ensuring timely release of