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Let's push the boundaries together and make the most of your talents!

QA GMP Specialist

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  68592

QA GMP Specialist

 

Help us transform patients' lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases.  Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in this pioneering adventure? 

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 UCB QA GMP Specialist, you like to work in an environment where you can:  

  • Support operational Quality Assurance activities for UCB’s biological development projects.
  • 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. ….
  • This will be achieved through close partnering with QA at UCB and vendor sites, and collaboration with UCB Technical Operations and other UCB teams.

 

As a UCB QA GMP Specialist, 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

 

 

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

Apply now »