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Quality Assurance Specialist

vor 2 Monaten

Bern, Bern, Schweiz CSL Behring Vollzeit
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at CSL Behring. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities
  • Quality Assurance Systems Management

You will be responsible for maintaining and ensuring the effectiveness of our Quality Assurance Systems, including affiliate quality management systems, to ensure compliance with company standards and regulatory guidelines.

Learning Management System Administration

You will manage our affiliate Learning Management System, ensuring that all necessary training and development programs are in place to support the quality and compliance of our products and processes.

Collaboration with Site QA

You will work closely with our Site QA team to ensure timely release of products to the market, while maintaining the highest standards of quality and compliance.

Investigations and Reporting

You will support investigations and affiliate recalls, and ensure that all necessary reporting and remedial actions are implemented to maintain the quality and compliance of our products and processes.

Customer Inquiries and Support

You will collaborate across departments to resolve customer inquiries and provide support on quality-related matters, including temperature storage concerns.

Procedure Maintenance and Training

You will maintain all procedures (SOPs, work instructions) within your responsibility and provide quality-related training to the affiliate team.

Inspection Readiness

You will ensure that the affiliate is inspection-ready at all times, meeting the highest standards of quality and compliance.

Quality Agreements Management

You will work with Global Supplier Quality to manage Quality Agreements, ensuring that all necessary agreements are in place to support the quality and compliance of our products and processes.

Requirements
  • Education

You must have a Bachelor's degree in a relevant scientific discipline, such as Pharmacy, Chemistry, Biology, or Biochemistry.

Experience

You must have at least 5 years of GMP experience in a pharmaceutical, biotech, or other regulated industry.

Global Matrix Organization Experience

You must have experience working within a global matrix organization.

Knowledge and Skills

You must have knowledge of current Good Manufacturing Practices (cGMP) principles and regulatory requirements. You must also have strong language skills, with proficiency in German, English, and French (beneficial).