System Specialist for Pharmaceutical Manufacturing

Vor 4 Tagen


St Gallen, Sankt Gallen, Schweiz CSL Vifor Vollzeit

We are seeking a System Specialist to join our team at CSL Vifor in St. Gallen, Switzerland.

Your primary responsibilities will include:

  • Providing support on Good Manufacturing Practices (GMP) processes to ensure compliance with company standards and regulatory guidelines.
  • Developing, maintaining, and improving GMP-related Standard Operating Procedures (SOPs).
  • Supporting quality processes related to Validation, Qualification, Document Management, Deviation Management, Corrective Action Preventative Action (CAPA), and Change Control in the Site GMP areas.
About the Role

This position reports directly to the Head QA Compliance and Innovations.

Key Responsibilities

The successful candidate will be responsible for ensuring compliance with processes and legal regulations, conducting training, managing RA standard processes, handling IT-tickets, updating SOPs and manuals, introducing issue management processes, preparing migrations to GMP systems, and archiving historical data.

They will also provide shop floor assistance for DEV/CAPA and CC management, support change controls, DEVs, and CAPAs, improve data quality, conduct self-inspections, and assist during audits.

Your Profile

To be successful in this role, you should have:

  • A Bachelor's degree in Chemistry, Biology, Microbiology, or a related field.
  • 3-5 years of experience in quality systems within pharmaceutical manufacturing/cGMP regulated environments.
  • Demonstrated practical experience in process improvement and optimization.
  • Strong experience in managing end-to-end processes in a pharmaceutical production environment.
  • Fluency in English and German.
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.



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