GMP Quality Assurance Professional
vor 16 Stunden
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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Compliance and System Specialist
vor 16 Stunden
St. Gallen, Sankt Gallen, Schweiz CSL Vifor VollzeitJob DescriptionWe 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...
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Accreditation and Quality Assurance Manager
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Quality Assurance Specialist
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St. Gallen, Sankt Gallen, Schweiz Pharmiweb VollzeitCompany Overview">Pharmiweb is a leading life sciences recruiter specializing in finding exceptional talent for top companies globally.
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St. Gallen, Sankt Gallen, Schweiz CSL Vifor VollzeitWe 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...
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St. Gallen, Sankt Gallen, Schweiz Universität St. Gallen VollzeitJob ResponsibilitiesThe Accreditation Manager will play a key role in maintaining and enhancing the University's accreditation status.Responsibilities include:Managing accreditation activities and impact measurement.Preparing and submitting accreditation documentation.Conducting data collection and analysis.Coordinating site visits and facilitating...
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vor 16 Stunden
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vor 16 Stunden
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Quality Audit Management Lead
Vor 6 Tagen
St. Gallen, Schweiz Vifor Pharma Vollzeit-We are currently looking for a Quality Audit Management Lead to join our team in St. Gallen. In this position you will have overall responsibility & accountability for the oversight and management of CSL Vifor GxP Quality Assurance audit programs including GMP, GDP, and Clinical, Medical, Regulatory & Safety (CMRS) aspects in line with existing regulations....
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vor 1 Woche
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St. Gallen, Schweiz Vifor Pharma Vollzeit-CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead...
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St. Gallen, Schweiz CSL Behring VollzeitWe are currently looking for a Quality Assurance Manager /Specialist CMO/ Supplier Management Oral Products to join our team in St Gallen. **Main Responsibilities** - Management of CMOs and Suppliers for the oral portfolio. - Processing all quality related tasks for the outsourced manufacturing and services to different contract manufacturing organizations...
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vor 1 Woche
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