Partner Cts Quality Operations - Braine-l'Alleud, België - UCB S.A.

UCB S.A.
UCB S.A.
Geverifieerd bedrijf
Braine-l'Alleud, België

1 maand geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving

Make your mark for patients.
We're here because we want to build the future and transform patients' lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive.

That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients.

We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?


To strengthen our
Quality Assurance team
, we are looking for a high caliber, self-motivated, CTS Quality Operations Partner & QP
based in Braine l'Alleud, Belgium.**
At UCB everything we do starts with a simple question: "How will this make a difference to the lives of people living with severe diseases?" We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders.

Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.



You like to work in an
environment where you can:

  • Acts as QP according to current regulation for Investigational Medicinal Products and are responsible for the management of batch disposition and release activities concerning the provision of IMP for UCB sponsored Clinical Trials.
  • Act as Responsible Person, as per definition in the Good Distribution Practices.
  • As a member of the GMP/GPS Quality Operations team,you will be responsible for, but not limited to the QA review of IMP batch records, ensuring the prompt resolution of all batch manufacturing issues and ensuring close out of development related CAPAs. This role provides direct partner driven, pragmatic and proactive support for development manufacturing. The Partner CTS Quality Ops and/or QP is responsible for QA release support during regulatory inspections, and quality improvement initiatives.
  • In addition, you will be responsible for ensuring that appropriate quality systems are in place for the production and release of IMP for Clinical trials as required by the development team.
  • Ensure the manufacture, certification and distribution of Investigational Medicinal Products, is according to: EC GMP guidelines (EudraLex
  • The Rules Governing Medicinal Products in the European Union, volume last edition) Clinical Trials Regulation EU No 536/2014 and associated documents. Principe of Good Distribution Practices as required in EC Directive 2013/C68/0
  • Provide timely and efficient GMP/GDP IMP Release function to all relevant UCB project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc ).
  • Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc
  • Participate in the management of QA through active participation in QA forums and other meetings.
  • Support inlicensing activities by providing Quality Assurance expertise for the evaluation of new project opportunities including participation in due diligence activities.
  • To support the systems and processes in place for the appropriate documentation of UCB development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
  • Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, relevant). Support the Head of CTS Quality Operations in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities.
  • Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions.

Interested? For this position you'll need the following
education, experience
and skills:

  • Experience in pharmaceutical regulated environment, with at least five years of practical experience in drug research and development or drug production quality management, including at least one year of drug quality management experience.
  • Must be knowledgeable in QA
  • A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
  • QA/compliance experien
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