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QA GMP Specialist

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  65596

QA GMP Specialist

 

To strengthen our Global Quality Assurance department, based in our hub in Braine l’Alleud, we are looking for a talented individual to fill the position of: QA GMP Specialist

As a QA GMP Specialist, you will support operational Quality Assurance activities for UCB’s biological development projects.

This will be achieved through close partnering with QA at UCB and vendor sites, and collaboration with UCB Technical Operations and other UCB teams.

 

You like to work in an environment where you can:

  • Work closely with Technical Operations teams to ensure that all QA services for the project are provided in an effective and efficient way
  • Provide advice and support on operational and general QA activities to UCB teams working on Drug Substance (DS) and Drug Product (DP) development, Technology transfer, manufacture and submission preparation. ….

 

You will contribute by:

 

Manufacturing and Disposition Support:

  • Review and approval of manufacturing and disposition documentation, for example:
    • Process description, master batch records
    • Analytical methods, specifications
    • Completed Internal & CMO batch documentation
    • Deviations, Change controls, CAPA 
  • Release of raw materials & consumable used for therapeutic proteins production in SAP

 

Auditing and Spot Checking:

  • Follow up of audits observations
  • Plan and manage shop floor spot-checks of the GMP area, offering quality assurance support including, but not limited to inspection.

 

The review will include :

  • Check of referenced documents and data
  • Compliance with relevant protocol, SOP or GMP guideline
  • Compliance with regulatory guidelines
  • Deviations and changes are properly addressed and documented
  • Consistency with other documents
  • Discussions and conclusions are pertinent and consistent with data
  • Comments from review are correctly addressed

 

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

  • Minimum of 2 years working in the pharmaceutical biologics industry in a quality assurance position. Operational GMP experience would be a distinct advantage.

 

  • Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations together with quality principles and techniques.
  • Experienced in one or more of the following:
    • regulatory submission preparation for biological products
    • ICH Q2 analytical method validation principles and general analytical techniques
    • GMP process validation
    • DS and/or DP process manufacture for biological products
  • Demonstrate initiative and an ability to help team and others solve problems creatively
  • Ensure free flow of information to the appropriate stakeholders
  • In-depth knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques
  • Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the business
  • Understand practical applications of GMP, compliance principles and theories incl. risk management

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 


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