Manufacturing Science Quality Operations Specialist

Vor 4 Tagen


St Gallen, Sankt Gallen, Schweiz TN Switzerland Vollzeit

About the Role:

As a key member of our team, you will be responsible for ensuring product knowledge within CSL Vifor for providing best support for our CMOs and analytical service providers.

This role involves management of Quality Control/Manufacturing Science and QA activities for CMOs/suppliers of the oral portfolio. You will ensure knowledge of manufacturing processes, QC-analytical methods, drug products, APIs, and raw materials.

You will act as SME (Subject Matter Expert) for PQR/APR of external manufactured products and conduct, execute, and document impact assessments and investigations.

In addition, you will provide overview about Quality Performance of CMOs (CPV) and product-related data, and perform QC-releases for Oral Products.

Key Responsibilities:

  • Management of Quality Control/Manufacturing Science and QA activities
  • Ensure knowledge of manufacturing processes and QC-analytical methods
  • SME for PQR/APR of external manufactured products
  • Conduct, execute, and document impact assessments and investigations
  • Provide overview about Quality Performance of CMOs (CPV)
  • Perform QC-releases for Oral Products

Requirements:

  • 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 and/or for data analysis
  • Team player
  • Fluent in English and German is an asset


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