Quality Validation Specialist

Eisai EMEA; Hatfield; Hybrid; GBP 35,000 - 55,000; Full time

Job description

The Company

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas.

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 Quality Validation Specialist, you will be responsible for ensuring that electronic systems within the Quality Control Laboratory and the Quality Systems operate in accordance with the requirements of the departmental Standard Operating Procedures.

Ensuring EML’s Electronic TrackWise Quality Management System (QMS) and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and Eisai Corporate expectations.

Provide input to the review and writing of any associated quality policies, systems and procedures as required.

Support the maintenance and administration of EML’s Electronic TrackWise Quality Management System (QMS) to maintain an effective QMS to meet EML’s requirements.

Support the effective management of the administration of QC laboratory system applications providing independence of access for administrator activities.

Ensure Qualification and Validation of EML equipment, processes, systems is/are performed in line with EML procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required.

Ensure the maintenance of EML procedures supporting Qualification and Validation ensuring they are current with updated requirements for Qualification and Validation and cGMP, cGxP expectations.

Ensure user access to systems is maintained in line with procedures and support is provided to facilitate the set up and change management of system data and ensure continuous system availability and functionality.

What are we looking for?

• 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.
• Proficient knowledge of electronic systems, CSV and GAMP requirements.
• Good understanding of the requirements of data integrity and application to system management.
• Good understanding of Quality Control Systems and analytical software and electronic Quality Systems.
• 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.
• Good understanding of GMP Guidelines and Regulations.
• Knowledge of the qualification and validation requirements for equipment and electronic systems.
• 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:

• Hybrid working (Depending on role).
• Car/Car Allowance (Depending on role).
• 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.

What you need to do next

If you are interested in this position, please click ‘apply now’ at the top of this advert. Upon submitting your application, you will be asked to complete your profile and upload a copy of your CV along with any additional information to support your application.

If you have any questions, please contact us on [e-mail].

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.