Quality Operations Manufacturing Science QC
Quality Operations Manufacturing Science QC Support Manager
In this role 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 of manufacturing processes, QC-analytical methods, drug products, APIs and raw materials
SME (Subject Matter Expert) for PQR/APR of external manufactured products
SME for Stability Studies of external manufactured products
Data collection, creating, review and approval of stability reports
Support for regulatory submissions and variations in close cooperation with global and local stakeholders
Creating, Review and approval of compliance records (Changes, complaints, deviation) and other documents
Conduct, execute and document impact assessments and investigations
Providing overview about Quality Performance of CMOs (CPV) and product related data
Support analytical method transfer to external analytical service providers/CMOs
Providing overview on deviations, complaints and follow-up of defined actions for improving Right First Time at CMOs
Performing QC-releases for Oral Products
Qualification and experience
Bachelor / Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
Minimum 5 years overall experience within the pharmaceutical, biotechnology, or medical device industry
Experience in Quality Control, Pharm. Manufacturing or Stability Management
Experience with software for Quality processes (e.g. Trackwise) and / or for data analysis (e.g. PowerBI, Excel, Minitab)
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
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Vifor is committed to provide equal employment opportunity for all.
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.
For more information, please visit viforpharma.com
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
