Quality Operations Associate - Permanent Position

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

Quality Operations Associate - Permanent Position

Location: Mosquito Way, Hatfield AL10 9SN, UK

Highlighted points for this job

Quality Operations Associate role at Hatfield Knowledge Centre

Supporting EML Quality Systems and Assurance activities

Competitive salary and benefits package

Requirements include knowledge of Quality Systems, GMP and pharmaceutical manufacturing

Eisai promotes diversity and inclusion

Location: Hatfield Knowledge Centre

Full time onsite

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

We are look for a Quality Operations Associate to support EML Quality Systems and Assurance activities for the manufacture, packaging, testing, storage and distribution of EML and third-party contract manufactured drug products, ensuring compliance with current GMP, Eisai Quality Systems, Eisai Corporate expectations and Industry Standards Support the review and writing of quality policies, systems and procedures as required.

Supporting the effective implementation, by all stakeholders, of aspects of the operational Quality Management System (QMS), including, but not limited to, Product Quality Reviews, Quality Agreements, Parallel Imports, Change Control, Risk Management, Deviations/Incidents, Training, Documentation, Internal and External Audits, Approved Supplier Systems and use of the TrackWise eQMS within Eisai Manufacturing Limited.

What are we looking for?

• Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
• Basic knowledge of Quality Systems, Quality Assurance, GMP and basic understanding of 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
• Basic understanding of GMP Guidelines and Regulations

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.

• 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