Quality Assurance Specialist

vor 4 Wochen


Bern, Bern, Schweiz CSL Behring Vollzeit
Job Title: Local Quality Officer

We are seeking a highly skilled Local Quality Officer to join our team at CSL Behring. As a key member of our quality assurance team, you will be responsible for maintaining Quality Assurance Systems and ensuring compliance with company standards and regulatory guidelines.

Key Responsibilities:

  • Maintain Quality Assurance Systems to ensure compliance with company standards and regulatory guidelines
  • Manage affiliate Learning management system to ensure timely release of products to the market
  • Closely collaborate with site QA to assure timely release of products to the market
  • Support investigations/affiliate recalls and reporting of product technical complaints and ensures remedial actions are implemented
  • Collaborate across departments to resolve customer inquiries and possible temperature storage concerns
  • Keep all procedures (SOPs, work instructions) in your responsibility up to date and provide quality related training to the affiliate team
  • Assure inspection readiness of the affiliate
  • Support management of Quality Agreements with Global Supplier Quality

Requirements:

  • Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
  • 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
  • Experience within a global matrix organization
  • Knowledge of current Good Manufacturing Practices (cGMP) principles
  • Knowledge of regulatory requirements
  • Language requirements: German, English, (French beneficial)

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 value diversity and inclusion:

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. We believe that a diverse and inclusive workplace is essential to our success and to delivering the best possible outcomes for our patients.



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