Compliance and System Specialist

vor 17 Stunden


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

We are seeking a highly skilled professional to provide critical support for our quality processes in the Site GMP areas. As a QA Compliance and System Specialist, you will be responsible for ensuring compliance with company standards and regulatory guidelines, developing and maintaining GMP-related standard operating procedures (SOPs), and supporting various quality processes.

This position involves 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.

Key responsibilities include introducing, monitoring, and issue managing processes, preparing and executing migrations to GMP systems, and archiving historical data. Additionally, you will support R&D with 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.

We require a Bachelor's degree in Chemistry, Biology, Microbiology, or a related field. A minimum of 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment is also essential. 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 required. Fluency in German and good knowledge of English are necessary for this role.

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