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QA Associate Analytical Services

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  66266

QA Associate Analytical Services

Braine L'Alleud, Belgium

 

To strengthen our Braine Technical Operations team, based in our hub in Braine, Belgium, we are looking for a talented individual to fill the position of: QA Associate Analytical Services.

As a QA Associate Analytical Services, you will be responsible to assure that technical operations and quality systems related to the analyses of pharmaceutical products comply with applicable regulations, guidelines and corporate policies/procedures.

 

You like to work in an environment where you can:

  • Support Quality Control operations with technical expertise and pragmatism in problem solving exercises.
  • Provide Quality leadership, be an exemplary UCB representative in your field and communicate effectively towards multiple internal/external stakeholders.
  • Participate to and drive the implementation of various types of projects linked to the QC laboratories and Quality department

 

You will contribute by:

 

  • Using a Risk Based Approach, ensure that all Braine Quality Control Systems and Operations are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures
  • Assuring that pharmaceutical products get analyzed and analytical results validated in accordance with UCB Quality Systems, Standards and applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH)
  • Ensuring effective follow-up of Deviations, OOS Investigations, Failure Investigations, Change Control, Qualification/Validation activities, Compliance Audit activities and documentation approval related to the QC Systems & Operations
  • Identifying, developing and implementing technically robust/compliant Quality Systems together with Quality Control management, in response to continuous improvement opportunities or regulatory/business requirements, changes, risks and audit observations at the Braine site.
  • Driving quality leadership and technical expertise on QC System compliance strategy and interact with other functional areas to effectively communicate Quality requirements.
  • Ensuring pro-active and adequate communication of compliance status and issues to appropriate levels of the organization.
  • Implementing and maintaining relevant Quality & Compliance indicators and communicate results to appropriate levels of the organization.
  • Participating in the preparation of audits/regulatory inspections, provide dynamic support to System Owners and be an active member during audits/inspections.
  • Leading or co-leading internal audits to ensure compliance with UCB standards and worldwide regulatory requirements with respect to cGMP.
  • Ensuring an adequate cGMP level of subcontractors of Braine Technical Ops and related supporting services.
  • Ensuring effective coaching and training of all relevant stakeholders on the Quality Management System, GMP’s and the correct usage hereof.
  • Identifying, coordinating or supporting Continuous Improvement projects (LEAN, 6-Sigma and other).
  • Promoting quality and operational excellence and cultivate “SOSD” (See it, Own it, Solve it, Do it) attitude across Braine Technical Ops and related supporting services.
  • Interacting with multiple internal/external stakeholders like support departments, Regulatory Affairs, Operational Excellence, Inspectors/Auditors, etc.
  • Acting as back-up for his direct colleagues or for his Manager according to the manager’s instructions and after appropriate training.

 

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

 

  • Master’s degree related to the field of activity
  • At least 5 years of experience in a comparable role
  • Strong knowledge and proven experience in analytical techniques
  • Team player; ability to share good practices and knowledges
  • Ability to take initiative and work both independently and in a team environment
  • Strong analytical mindset
  • Curious and constantly willing to learn
  • Able to take the necessary leadership in project implementation
  • Full professional proficiency in French and English (both oral and written)

 

 

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.

 

Apply now »