Quality Assurance Specialist
vor 4 Wochen
About the Role:
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:
- Develop and implement quality assurance systems to ensure compliance with regulatory requirements
- Collaborate with site QA to ensure the release of products to the market
- Support investigations and reporting of product technical complaints and ensure remedial actions are implemented
- Collaborate across departments to resolve customer inquiries and temperature storage concerns
- Develop and maintain procedures (SOPs, work instructions) and provide quality-related training to the affiliate team
- Ensure inspection readiness of the affiliate
- Support the 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
- Business fluency in German and English is required
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.
Why Join Us:
We value diversity and inclusion and strive to create a workplace that reflects the world around us. We encourage you to make your well-being a priority and offer a range of benefits to support your health and happiness.
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