Beschreibung

Location: Bulle, Switzerland

Activity rate : 100%

Type of contract: Temporary contract (6 months)

Start Date: ASAP

The Quality Specialist is responsible for ensuring product delivery compliance with national and international regulations, while supporting operational excellence and quality improvements. This role involves managing quality processes, including deviations, CAPAs, change controls, and validations, to meet UCB's high standards in Security, Quality, Time, and Cost. Collaboration with internal and external stakeholders is key to driving continuous improvement and maintaining a culture of quality across departments.

Key responsibilites:

• Provide quality support for product delivery, ensuring compliance with GxP and UCB standards.
  • Manage deviations, CAPAs, change controls, complaints, and other quality-related processes.
    • Ensure equipment and processes are qualified and validated according to guidelines.
      • Participate in internal audits, inspections, and the preparation of SOPs and other documentation.
        • Contribute to Product Quality Reviews (PQR) and Continuous Process Verification (CPV).
          • Support the achievement of team objectives and process improvements.
            • Collaborate with manufacturing, supply chain, and technical services for operational excellence.
              • Identify and implement quality and compliance improvements in daily operations.
                • Maintain a "inspection readiness" status in all activities.
                  • Promote a culture of quality and continuous improvement within the organization.
                    • Ensure effective communication of quality issues and compliance status with all relevant stakeholders.
                      • Act as a point of contact for quality-related questions and guidance on the production floor.

                        
                        

                        qualifications

                        What will make you successful:

                        • Master's degree in a relevant field (e.g., Life Sciences, Pharmacy, Chemical Engineering, or Quality Management).
                          • Minimum of 4 years of experience in quality assurance, focusing on deviations, non-conformities, and operational quality.
                            • Proven ability to work independently and manage shifting priorities.
                              • Experience coordinating multifaceted projects and meeting critical deadlines.
                                • Strong collaboration skills with operational teams in manufacturing environments.
                                  • Solid understanding of GxP environment and technical competence in medicinal product manufacturing.
                                    • Experience in writing scientific and technical documents and promoting quality culture at the shop floor level.
                                      • Excellent communication skills in both French and English, with the ability to engage diverse stakeholders.