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Braine-l'Alleud

    Documentation & Training Manager - Braine-l'Alleud, België - UCB

    UCB
    UCB Braine-l'Alleud, België

    4 dagen geleden

    ucb background
    Beschrijving

    Make your mark for patients

    We are seeking a Documentation and Training Manager who is passionate about compliance and excellence to join our team at the Biologics Pilot Plant, located on our UCB campus in Braine l'Alleud, Belgium.

    About the Role

    As the Documentation and Training Manager, you will play a pivotal role in ensuring the smooth operation of our Biologics Pilot Plants. You will be responsible for managing documentation and training systems, in the area of monoclonal antibodies manufacturing and Gene Therapy.

    Who You'll Work With

    You'll collaborate closely with cross-functional teams, including project teams, production entities, and quality assurance, to ensure alignment with regulatory standards and internal practices.

    What You'll Do

    Document/Data Management/Digitalization:

  • You will be accountable for overseeing the management of both paper and electronic documents within the Biologics Pilot Plant and the future Gene Therapy Plant.
  • As an expert, you will lead initiatives for guaranteeing and reinforcing good documentation practices.
  • You will define and implement strategies for documentation management processes, ensuring compliance with regulations and internal standards.
  • You will guide initiatives to improve digital strategies and implementation, including and especially serving as a power user in the Electronic Document Management System (EDMS).

    • Knowledge, People Qualification, and Training Management:

  • You will ensure the development and maintenance of a comprehensive training matrix and associated training plans, in collaboration with managers and aligned with updated job descriptions.
  • You will maintain a list of trainers and single points of contact for all Standard Operating Procedures (SOPs), managing training, changes and updates efficiently.
  • Responsible for developing and delivering GMP training content and organizing training sessions for both the Biologics Pilot Plant and the future Gene Therapy Plant.
  • You will supervise the coaching strategy for the Biologicals Pilot Plants.
  • You will supervise the training schedule, sessions organization, and maintenance of training records, ensuring compliance with regulatory requirements.

    • General Quality Systems:

  • You will coordinate, prepare, and manage all documentation and training aspects for audits and quality meetings, ensuring readiness and compliance.
  • Define and track Quality Key Performance Indicators (KPIs) related to training, coaching, and documentation processes.
  • Conduct gap/risk analysis as necessary and steer continuous improvement projects related to training, documentation, and digitalization, in alignment with UCB's overarching processes.
  • Manage deviations and change controls related to training and documentation, ensuring timely resolution and compliance.

    • Interested? For this role, we're looking for the following education, experience, and skills:

  • Bachelor's degree in sciences
  • Minimum 5 years' experience in a regulated pharmaceutical company
  • Experience in a GMP environment
  • Experience in training management and documentation management (incl. eDMS)
  • Proficiency in deviation and change control management
  • Strong communication and problem-solving skills
  • Fluency in French and good knowledge of English, both written and spoken.

    • Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

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