GMP Quality Assurance Professional

vor 16 Stunden


St Gallen, Sankt Gallen, Schweiz CSL Vifor Vollzeit
About the Role

We are looking for a talented professional to join our team as a QA Compliance and System Specialist. In this role, you will play a critical part in ensuring compliance with company standards and regulatory guidelines, developing and maintaining GMP-related standard operating procedures (SOPs), and supporting various quality processes.

Your primary responsibilities will include ensuring compliance with processes and legal regulations, including conducting compliance training and managing RA standard management. You will also handle and manage IT-tickets and changes, as well as update and inactivate SOPs and manuals.

This position involves working closely with the R&D team to ensure global system integration and quality assurance during data and process transfer and archiving. Some of your key tasks will include optimizing and monitoring specific site processes, providing shop floor assistance for DEV/CAPA and CC management, and supporting change controls, DEVs, and CAPAs. You will also conduct self-inspections and assist during audits, manage RA standard management, and support local CSV projects.

To succeed in this role, you will need a Bachelor's degree in Chemistry, Biology, Microbiology, or a related field. At least 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment is also required. Demonstrated practical experience in process improvement/optimization and strong experience in managing end-to-end processes in a pharmaceutical production or relevant environment are also necessary. Fluency in German and good knowledge of English are required for this position.

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