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.

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.