Quality Operations Manufacturing Science Qc
vor 5 Monaten
At CSL Vifor we have established a new organizational model for managing important Contract Manufacturing Organization (CMO) partnerships. In this context, we are offering an exciting opportunity for our Quality Operations External API & Oral Products Department as
**Quality Operations Manufacturing Science QC Support** Manager**:
In this role you will report into the Head of Quality Operations External API & Oral Products. You will be responsible for ensuring product knowledge within CSL Vifor for providing best support for our CMOs and analytical service providers for external manufactured APIs and Finished Drug Products in the oral portfolio. Furthermore, you will be responsible for the following tasks:
- Management of Quality Control / Manufacturing Science and QA activities for CMOs/suppliers of the oral portfolio
- Ensure knowledge management of manufacturing processes, QC-analytical methods, drug products, APIs and raw materials
- Support for regulatory submissions
- Providing overview about Quality Performance of CMOs (CPV) and product related data (e.g. trending in stability studies)
- Support analytical method transfer to external analytical service providers/CMOs
- Support troubleshooting/root cause analysis activities at CMOs/suppliers
- Providing overview on deviations, complaints and follow-up of defined actions for improving Right First Time
- Support KPI Management for evaluation of CMOs/supplier performance
- Performing QC-releases for Oral Products
- Coordination and handling of relevant processes as change controls, deviations, validations in cooperation with other CSL Vifor departments as Supply Chain, Regulatory, Ext. Development, QPs
**Qualification and experience**
- Bachelor / Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
- Minimum 3 years overall experience within the pharmaceutical, biotechnology, or medical device industry
- Experience in Quality Control, Manufacturing or Stability Management
- Experience in lean management tools and Operational Excellence
- Experience with software tools for data analysis, e.g. PowerBI, Excel, Minitab
- troubleshooting, problem solving skills
- team player
- Fluent in English and German in an asset
**Preferred Requirements**
- working experience in different cultures
- working experience in Pharmaceutical/Analytical Development
- Audit experience
CSL Behring is committed to provide equal employment opportunity for all.
**About CSL Vifor**:
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Vifor**:
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