Quality Assurance Specialist in Pharmaceutical Manufacturing

Vor 2 Tagen

St Gallen, Sankt Gallen, Schweiz CSL Vifor Vollzeit
Job Description

We are seeking a Quality Assurance Specialist to join our team at CSL Vifor, a global leader in iron deficiency and nephrology. The successful candidate will be responsible for ensuring compliance with GMP processes and regulatory guidelines.

Main Responsibilities:
  • Provide support on GMP-related processes to ensure compliance with company standards and regulations;
  • Develop, maintain, and improve GMP-related standard operating procedures (SOPs);
  • Support quality processes related to Validation, Qualification, Document Management, Deviation Management, CAPA, and Change Control;
Key Tasks:
  • Ensuring compliance with legal regulations and conducting training;
  • Handling and managing IT-tickets and changes;
  • Updating and inactivating SOPs and manuals;
  • Introducing and monitoring issue management processes;
  • Preparing and executing the migration to GMP systems and archiving historical data;
  • Supporting R&D with global system integration and quality assurance during data and process transfer and archiving;
  • Optimizing and monitoring specific site processes;
  • Shop floor assistance for DEV/CAPA and CC management;
  • SUPPORTING CHANGE CONTROLS, DEVS AND CAPAS, DATA QUALITY IMPROVEMENTS;
  • Conducting self-inspections and assisting within audits;
  • RA standard management;
  • Supporting local CSV projects;
Your Profile:
  • Bachelor's degree in Chemistry, Biology, Microbiology, etc.;
  • 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment;
  • Demonstrated practical experience in process improvement/optimization;
  • Strong experience in managing end-to-end processes in a pharmaceutical production or other relevant environment;
  • Fluency in German and good knowledge of English;
Salary Range:

The estimated salary for this position is between $80,000 and $120,000 per year, depending on qualifications and location.

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