Quality Operations Specialist - GMP & QMS

Consortium; Hatfield; On-site; GBP 29,000 - 38,000; Full time

Benefits offered by this job

Electric charging points

Discretionary Bonus

Free onsite parking

Subsidised onsite restaurant

Learning and development opportunities

Well-being & mental health awareness

Multi-faith prayer room

Job summary

Eisai is seeking a Quality Operations Associate at the Hatfield Knowledge Centre to support EML Quality Systems and Assurance activities across the manufacture, packaging, testing, storage and distribution of Eisai drug products, ensuring current GMP compliance.

You will assist in reviewing and writing quality policies and procedures, and support the ongoing operation of the QMS and TrackWise eQMS, collaborating with internal teams and external partners to maintain high quality standards.

Qualifications

• Ability to establish and maintain effective working relationships with EML and affiliated organisations.
• Basic knowledge of Quality Systems, QA, GMP and pharmaceutical manufacture/packaging.

Responsibilities

• Support EML Quality Systems and Assurance activities for manufacture, packaging, testing, storage and distribution of drug products.
• Assist with review and writing of quality policies, systems and procedures.
• Support QMS implementation, including Product Quality Reviews, Change Control, Deviations/Incidents, Audits and TrackWise eQMS usage.

Skills

Relationship building

Quality Systems

GMP knowledge

Data interpretation

MS Office

Job description

Eisai is seeking a Quality Operations Associate at the Hatfield Knowledge Centre to support EML Quality Systems and Assurance activities across the manufacture, packaging, testing, storage and distribution of Eisai drug products, ensuring current GMP compliance.

You will assist in reviewing and writing quality policies and procedures, and support the ongoing operation of the QMS and TrackWise eQMS, collaborating with internal teams and external partners to maintain high quality standards.