QA Manufacturing Science

CSL Vifor
St. Gallen, SG, Switzerland
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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.

Key Tasks

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 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

Your Profile

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.

Minimum Requirements

Master Degree in Life Sciences

Minimum 3-5 years’ experience in Pharmaceutical Environment

Experience in Quality Control and / or Stability Management

Fluent in German and English

Preferred Requirements

Exposed to international experience

Lean experience

Use of statistical tools

Experience with combination products is a plus.

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.

For more information, please visit viforpharma.com

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!

Il y a 7 jours
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