Qualified Person, Belgium - Permanent Position

Qualified Person, Belgium - Permanent Position

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

As a Qualified Person this job is responsible and accountable for supporting the importation and batch certification for medicinal products into the European Union and providing Qualified Person confirmation for intermediates being imported into the European Union.
Additionally, the job holder will be responsible for the implementation and maintenance of the Quality Management System required to support a Manufacturing Import Authorisation (MIA).
Ensuring that operations are compliant with current GMP and Eisai Corporate expectations.  
Enhancing quality policies, systems and procedures as appropriate. 
Carry out legal duties of a Qualified Person (QP) as specified under EC directive 2001/83/EC (as amended and 2001/20/EC) and EU legislation.

What are we looking for?

• University degree in Industrial Pharmaceutical Science
• Registration on the list of Qualified Persons as required per RD 14/12/2006
• Able to initiate and maintain working relationships and communication links within affiliated organisations and third-party contractors.
• Extensive knowledge and experience of Quality Assurance, Quality Systems and GMDP across different dosage forms and across a Global basis.
• Knowledge on European regulations in relation to Manufacturing, Importation, Wholesale Distribution, Import, Export and Foreign trade , Guidelines on Good Manufacturing Practice (EU GMP) (Eudralex Volume 4), Guidelines on Good Distribution Practice (EU GDP) of medicinal products for human use (2013/C 343/01), European Community Directive D2001/83/EC relating to trade abroad activities, European Falsified Medicines Directive (2011/62/EU),  and the European Pharmaceutical Directive related to Wholesale Distribution of Medicinal Products (92/25/EEC)
• Good technical and scientific judgement.
• Fluency in English and French or Dutch

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package that includes,

• Discretionary Bonus
• Learning and development opportunities
• Well-being & mental health awareness programmes 

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 TalentAcquisition@eisai.net 

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