CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.
We are currently looking for a QA Manufacturing Science Manager for our Parenteral Products to join our team in St. Gallen. In this exciting position, you will be in charge of the Quality oversight of GMP data trending generated during operations throughout product lifecycle for parenteral products. You will be directly reporting to Head Quality Operations Parenteral Products.
- Support of method transfer to external parties
- Define, create and maintain data trending and evaluation related to parenteral products supporting Quality Operations as well as CMO global evaluation
- Organize and evaluate stability studies and -documents (routine and specific)
- Supporting RA CMC groups for regulatory submissions
- Writing of annual product quality review and stability reports
- Supporting CMO audit teams in your area of responsibility
- Give recommendations to parenteral team when it comes to preventive actions or corrective actions in the light of products knowledge.
- General QA tasks related to analytics and stability process
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
- Master’s degree in Life Sciences
- 3-5 years overall experience in Pharmaceutical Environment
- Experience in Quality Control and/or Stability Management
- Fluent in German and English
- Exposed to international experience
- Lean experience
- Use of statistical tools