Qa compliance and system specialist

Vor 2 Tagen


Saint Gallen, Schweiz CSL Vifor Vollzeit
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.
n this position you will be directly reporting to the Head QA Compliance and Innovations.
Key Tasks Ensuring compliance with processes and legal regulations, conducting compliance training, as RA standard management, etc.
Handling and managing IT-tickets and changes Updating and inactivating SOPs and manuals Introducing and monitoring and issue management process 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 Support of creating change controls, DEV`s and CAPA`s, data quality improvements Conducting self-inspections and help within audits  RA standard management, etc.
Supporting and implementing local CSV projects Your Profile Bachelor’s degree in Chemistry, Biology, Microbiology, etc.
 3-5 years' quality systems experience in pharmaceutical manufacturing/c GMP 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 in English Are you interested in this exciting opportunity? We are looking forward to receiving your online application.
About CSL Vifor CSL 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.com We want CSL to reflect the world around us As 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

  • Saint-Prex, Schweiz Manpower Vollzeit

    Key Responsibilities: Define, Implement, and Maintain Validation Systems: Develop, implement, and manage the validation/qualification/calibration system in accordance with cGMPs, 21 CFR Part 11, and GAMP5. Conduct analytical method validation, process and cleaning validation, as well as equipment and PLCs qualification. Support Industrial Projects: ...

  • QA Team Leader Release

    vor 6 Monaten


    Saint-Prex, Schweiz Ferring Pharmaceuticals, Inc. Vollzeit

    Job Description: At Ferring Pharmaceuticals, we help people around the world build families and live better lifes. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we...


  • St. Gallen, Sankt Gallen, Schweiz VAT Vollzeit

    OverviewVAT, a world-leading company in vacuum valves and vacuum sealing technology, is seeking an experienced IT Security Specialist to join our team. With over 50 years of innovation, we continue to push boundaries and meet our customers' evolving requirements.


  • Saint-Sulpice VD, Waadt, Schweiz Nagi Bioscience Vollzeit

    OverviewNagi Bioscience, a cutting-edge startup in the life science instrumentation field, seeks a highly skilled Manufacturing and Equipment Specialist to join their team. Headquartered in the EPFL Innovation Park, this opportunity offers a chance to be part of a groundbreaking journey in biological testing.SalaryThe estimated annual salary for this...


  • Saint-Sulpice, Schweiz Tandem Diabetes Care Switzerland Vollzeit

    **GROW WITH US**: Tandem Diabetes Care Switzerland Sàrl, a subsidiary of Tandem Diabetes Care, Inc., is a MedTech start-up located in EPFL’s Innovation Park in Lausanne, Switzerland. Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company based in San Diego, California. Together we are creating new possibilities for people...


  • Saint Gallen, Schweiz Sportradar Vollzeit

    Job DescriptionOVERVIEW:We are seeking an experienced and highly skilled Director of Financial Reporting and Technical Accounting to lead and oversee all aspects of external financial reporting, including SEC and audit committee reporting, as well as technical IFRS accounting matters.  This role is crucial to ensuring we are meeting our reporting...

  • Leiter:in Law

    vor 3 Monaten


    St. Gallen, Schweiz SAK St.Gallisch-Appenzellische Kraftwerke AG Vollzeit

    **Leiter:in Law & Compliance** **(80-100 %)**: **St.Gallen**: **: Die Abteilung Law & Compliance ist zentral für die rechtliche Absicherung und Risikominimierung in den Bereichen Netz, Produktion und digitale Dienste. Zu den weiteren Aufgaben zählen die Sicherstellung des internen Kontrollsystems, die Überwachung regulatorischer Veränderungen sowie die...


  • Saint-luc, Schweiz Lonza Vollzeit

    Switzerland, Visp Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...


  • Saint-Prex, Schweiz Ferring Holding SA Vollzeit

    FSMP Information System Senior ManagerApply locations St-Prex, Switzerland time type Full time posted on Posted 2 Days Ago time left to apply End Date: January 10, 2025 (30+ days left to apply) job requisition id R0032285Job Description:At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial...


  • Saint-Prex, Waadt, Schweiz FINDERS SA Vollzeit

    We are seeking an experienced Packaging Machinery Specialist to join our team at FINDERS SA, a leading international group specializing in providing quality inspection solutions. Job Summary:FINDERS SA is looking for a skilled technician with automation experience to strengthen our team. This role requires 60-80% travel to client sites in the European Union....


  • Saint-Prex, Waadt, Schweiz FINDERS SA Vollzeit

    Job Title: Mechatronics Automation SpecialistWe are looking for a motivated engineer with a technical background to join FINDERS SA, an international group specializing in providing packaging quality inspection solutions for the pharmaceutical, medical device, and food industries.This role requires a high degree of technical independence and regular travel...

  • Service Technician

    vor 3 Wochen


    St. Gallen, Sankt Gallen, Schweiz Otis College of Art and Design Vollzeit

    Job Summary">We are seeking a skilled Service Technician - Installation Specialist to join our team. As a key member of our installation team, you will be responsible for the installation and maintenance of our elevator systems in the St. Gallen region.About the Role">This is an excellent opportunity for a motivated and detail-oriented individual who is...


  • Saint-Imier, Schweiz The SWATCH Group Vollzeit

    Job description We are looking for an International Digital Media Specialist for our Marketing Department. Role Overview As International Digital Media Specialist, you will be responsible for developing and executing digital media plans aimed at enhancing Longines’ brand visibility and reaching target audiences effectively.Working collaboratively with...

  • Laundry Specialist

    vor 1 Monat


    Saint Moritz, Schweiz Kulm Hotel St. Moritz Vollzeit

    Laundry SpecialistExpected from 01.12.2024 - Season (3-4 months)TLNT1_CHThis is what you move with usBasic knowledge of lingerie/laundryPreparation and storage of clean linen according to the standards of a 5* luxury hotelOrganisation of department cleaningWorking at the ironerUse of professional machineryFolding linen (sponges, napkins etc.)Flexibility...

  • Miu Miu

    vor 3 Monaten


    Saint Moritz, Schweiz Miu Miu Vollzeit

    Founded in 1913 in Italy, the Prada Group was built on a tradition of excellence and with a vision of innovation. The Group, a world leader in the luxury sector, operates in more than 45 countries with the PRADA, Miu Miu, Church’s and Car Shoe brands, and has employees of over 100 nationalities. The acquisition of Pasticceria Marchesi 1824 has marked the...


  • Saint-Imier, Schweiz Compagnie des Montres Longines Francillon SA Vollzeit

    International Digital Media SpecialistThe companyLongines - famous for the elegance of its timepieces - is a member of the Swatch Group Ltd, the world's leading manufacturer of horological products. Based in Saint-Imier, Switzerland since 1832, Longines watchmakers enjoy an expertise steeped in tradition, elegance and performance. With generations of...


  • Sankt Gallen, Schweiz Bluesign System Partnership Vollzeit

    Be a part of the sustainable movement.Get involved in environmentally friendly and safe textile production.Bluesign is a globally operating company with its headquarters in St. Gallen, Switzerland. We offer solutions for textile and related industries to produce safe and environmentally friendly products. Our customers include major international brands,...


  • Saint-Prex, Waadt, Schweiz FINDERS SA Vollzeit

    We are looking for an experienced Packaging Automation Specialist to strengthen our team at FINDERS SA.As a key member of our team, you will be responsible for developing and implementing automation solutions in the packaging industry. Your expertise will enable us to improve efficiency and quality in our processes.The ideal candidate will have technical...


  • Saint Gallen, Schweiz Smith+Nephew Vollzeit

    Life Unlimited . Smith+Nephew ist ein führendes Medizintechnikunternehmen, das Technologien für ein Leben ohne Einschränkungen entwickelt und produziert. Als Clinical Specialist RECON 100% (f/m/x) in unserer Sales Organisation Schweiz für die Region Zürich & Ostschweiz sind Sie ein wichtiges Bindeglied zwischen unseren Kunde und unserer Sales...


  • Saint-Imier, Schweiz Longines Watch Co. Francillon Ltd. Vollzeit

    Job description We are looking for an International Digital Media Specialist for our Marketing Department. Role Overview As International Digital Media Specialist, you will be responsible for developing and executing digital media plans aimed at enhancing Longines’ brand visibility and reaching target audiences effectively. Working collaboratively with...