Responsibilities:
- You maintain Quality Assurance Systems/affiliate quality management system to ensure compliance with company standards and regulatory guidelines
- You manage affiliate Learning management system (entspricht dem Plateau Admin)
- You closely collaborate with site QA to assure timely release of products to the market
- You support investigations/affiliate recalls and reporting of product technical complaints and ensures remedial actions are implemented
- You collaborate across departments to resolve customer inquiries and possible temperature storage concerns
- You Keep all procedures (SOPs, work instructions) in your responsibility up to date and provide quality related training to the affiliate team
- You assure inspection readiness of the affiliate
- Together with Global Supplier Quality, supports management of Quality Agreements
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Qualifications:
- 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)
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
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. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!