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Quality Management System Documentation & Training SpecialistUCB • Bulle, Gruyere, Switzerland
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Quality Management System Documentation & Training Specialist

Quality Management System Documentation & Training Specialist

UCB • Bulle, Gruyere, Switzerland
Vor 30+ Tagen
Stellenbeschreibung

Make your mark for patients

We are looking for a Quality Management System Documentation & Training Specialist, who is eager to join us in our QA Compliance Operations department, based in our manufacturing site in Bulle, Switzerland.

About the role

As a QMS Doc & Training Specialist, you will play a key role in maintaining, developing, and continuously improving QMS Documentation and Training processes, systems, records, and master data. You will ensure compliance with GMP requirements while contributing to quality excellence, operational performance, and lead digital innovation projects across the organization.

This role is ideal for a Quality professional who is passionate about combining compliance, process optimization, data management, and technology to deliver sustainable improvements and support a strong Quality Culture.

What you’ll do

  • Drive continuous improvement, harmonization, and simplification initiatives across QMS Documentation and Training processes.
  • Lead digital transformation projects within QA documentation management, supporting the transition towards more efficient, data-driven, and paperless ways of working.
  • Leverage innovative technologies and approved AI-enabled solutions to enhance quality processes and operational performance.
  • Monitor, analyze, and maintain quality data to support data integrity, compliance, reporting, and informed decision-making.
  • Support the evolution and optimization of Quality Management System (QMS) processes, systems, and tools.
  • Contribute to the management ofQMS Documentation and Training systems, records, and master data throughout their lifecycle.
  • Ensure accuracy, consistency, compliance, and archiving of documentation and training records.
  • Maintain training matrices, curricula, documentation metadata, and quality records.
  • Provide guidance and support to stakeholders on documentation and training processes.
  • Support audit readiness and participate in internal and external audits and inspections.
  • Promote a strong Quality Culture by ensuring compliance with GMP requirements and quality standards.
  • Contribute to cross-functional projects that enhance quality, compliance, and operational excellence.

Interested? For this role we’re looking for the followingeducation, experienceand skills

  • Bachelor's degree or equivalent experience in a scientific, pharmaceutical, quality, documentation, training, or related field.
  • Proven experience driving process improvement, harmonization, digitalization, or transformation initiatives.
  • Strong understanding of data integrity principles and quality data management.
  • Significant experience within the pharmaceutical industry and a GMP-regulated environment.
  • Strong customer focus, collaboration skills, agility, adaptability, and a continuous improvement mindset.
  • Strong knowledge of Quality Management Systems (QMS), compliance requirements, and audit readiness.
  • Experience managing quality documentation, training systems, and associated data throughout their lifecycle.
  • Experience working with QMS platforms such as LMS, eDMS, eQMS, or similar systems.
  • Lean Six Sigma Green Belt certification is preferred.
  • Experience supporting audits, inspections, and presenting quality processes in a regulated environment.
  • Experience contributing to the development and deployment of digital and AI-enabled solutions in a QA GxP environment, supporting process digitalization and paperless ways of working.
  • Fluent French and professional proficiency in English.

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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Quality Management System Documentation & Training Specialist • Bulle, Gruyere, Switzerland