Senior Scientific Expert, QA Support Functions

vor 2 Wochen


Bern, Bern, Schweiz CSL Behring Vollzeit
Job Title: Senior Scientific Expert, QA Support Functions

As a Senior Scientific Expert, QA Support Functions, you will play a critical role in ensuring the quality of our services and products. Your primary responsibility will be to perform routine and non-routine quality oversight activities in collaboration with various teams, including Maintenance & Utilities, Quality Control, local warehousing, and internal transports.

Your Key Responsibilities:

  • Partner with stakeholders to maintain compliance and adhere to QA standards.
  • Provide Quality Assurance oversight and facilitate quality decisions jointly with stakeholders in maintenance, utilities engineering, quality control, and local warehouse.
  • Conduct periodic quality oversight floor tours in warehouse with warehouse supervisor and Supply Chain for improvement and exception handling.
  • Manage complex and cross-functional local deviations, including initial risk assessments, Quality on the Floor oversight, and deviation reports.
  • Expert for cross-functional change management, managing complex minor, moderate, and cross-functional change requests.
  • Review and completion of APR/PQR regarding raw material data and review for trending and clusters for rejected lots.
  • Review and approve GxP documentation, including complex documents.

Requirements:

  • Master or Graduate university degree in a relevant discipline.
  • 3+ years of experience working in a similar role.
  • Sound expertise in cGMP and compliance.
  • Material management and warehousing & logistics.
  • Quality control & analytical methods.
  • Experience in change control, deviation management, CAPA management.
  • Strong communication, collaboration, and influencing skills.
  • Fluent German and English.

About CSL Behring:

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular, and metabolic, respiratory, and transplant therapeutic areas.

We want CSL to reflect the world around us:

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.



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