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

Qualified Person for Clinical Trial Supplies

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  64971

 Qualified Person (for IMP)

 

 

 

Help us transform patients’ lives.

 

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

To strengthen our Clinical Trial Supply QA team, based in our hub in Braine, Belgium, we are looking to fill the position of: Qualified Person for clinical trial supplies.

 

Are you driven and enjoy being innovative? For UCB, we see you as a ‘drivenovative’ person. This extraordinary blend of talent means you are adept at tenaciously sparking positive change for patients' lives.

 

As a UCB 'drivenovative' person and Qualified Person for clinical trial supplies you like to work in an environment where you can:

  • Be a key decision player, as part of an enthusiastic team
  • Participate in cross-functional meetings and projects
  • Work in a challenging and motivating environment
  • Deploy your continuous improvement and problem-solving skills

 

As a UCB 'drivenovative' person and Qualified Person for clinical trial supplies you will contribute by:

  • Acting as Qualified Person for IMP batch release (batch disposition and release activities concerning the provision of IMP for UCB sponsored Clinical Trials) and ensuring the prompt resolution of all batch manufacturing (internal or external) and supply issues.  
  • Providing direct partner driven, pragmatic and proactive support for development packaging and supply activities (distribution to depots and clinical sites, complaints management, …); escalate issues when required
  • Acting as key partner and support during regulatory inspections, audits, quality improvement initiatives or projects.  
  • Ensuring that appropriate quality systems are in place and followed for the production and release of IMP for Clinical trials.
  • Participating in identifying, developing and implementing 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 address problems and developing solutions.

 

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

  • Master in Pharmaceutical Industry – Qualified Person (approved by AFMPS/FAMHP)
  • 5 to 10 years’ experience in pharmaceutical industry with minimum experience in quality assurance or QP role in pharmaceutical regulated environment
  • A comprehensive knowledge of current regulatory requirements and ability to interpret current regulations is required.
  • Function effectively with minimal supervision
  • Good teamwork and project management skills. Must have strong, organization and analytical skills.
  • Must be fluent in English, other languages are a bonus
  • Facilitator, influencer and planer
  • Fact based decision maker: understand complex issues and have the ability to contribute to informed decision making when working on “grey” issues
  • Able to make or influence quality decision in a CMC development environment
  • Master problem solving and risk analysis techniques
  • Excellent interpersonal, verbal, and written communication skills are required, with ability to balance multiple priorities and provide prioritization

 


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