We are currently looking for a QA Compliance and System Specialist to join our team at our site in St. Gallen. Your main responsibilities will include: providing support on GMP processes to ensure compliance with company standards and GMP regulatory guidelines; developing, maintaining and improving GMP-related standard operating procedures (SOPs); supporting quality processes related to Validation, Qualification, Document Management, Deviation Management, CAPA and Change Control in the Site GMP areas.In this position you will be directly reporting to the Head QA Compliance and Innovations.Key TasksEnsuring compliance with processes and legal regulations, conducting compliance training, as RA standard management, etc.
We are currently looking for a QA Compliance and System Specialist to join our team at our site in St. Gallen. Your main responsibilities will include: providing support on GMP processes to ensure compliance with company standards and GMP regulatory guidelines; developing, maintaining and improving GMP-related standard operating procedures (SOPs); supporting quality processes related to Validation, Qualification, Document Management, Deviation Management, CAPA and Change Control in the Site GMP areas.In this position you will be directly reporting to the Head QA Compliance and Innovations.Key Tasks
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Handling and managing IT-tickets and changesUpdating and inactivating SOPs and manualsIntroducing and monitoring and issue management processPreparing and executing the migration to GMP systems and archiving historical dataSupporting R&D with global system integration and quality assurance during data and process transfer and archivingOptimizing and monitoring specific site processesShop floor assistance for DEV/CAPA and CC managementSupport of creating change controls, DEVs and CAPAs, data quality improvementsConducting self-inspections and help within auditsRA standard management, etc.Supporting and implementing local CSV projectsYour ProfileBachelor’s degree in Chemistry, Biology, Microbiology, etc.3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environmentDemonstrated practical experience in process improvement/ optimizationStrong experience in managing end to end processes in a pharmaceutical production or other relevant environmentFluency in German and good knowledge in EnglishAre you interested in this exciting opportunity? We are looking forward to receiving your online application.About CSL ViforCSL 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. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit viforpharma.comWe want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.Do work that matters at CSL Vifor!
