Quality Operations Manufacturing Science QC Specialist

vor 3 Wochen

St Gallen, Sankt Gallen, Schweiz CSL Vollzeit

Quality Operations Manufacturing Science QC Role

In this position, you will be responsible for ensuring product knowledge within CSL Vifor for providing best support for our CMOs and analytical service providers for external manufactured APIs and Finished Drug Products in the oral portfolio.

You will be responsible for the following tasks:

  • Management of Quality Control / Manufacturing Science and QA activities for CMOs/suppliers of the oral portfolio
  • Ensure knowledge of manufacturing processes, QC-analytical methods, drug products, APIs and raw materials
  • SME (Subject Matter Expert) for PQR/APR of external manufactured products
  • SME for Stability Studies of external manufactured products
  • Data collection, creating, review and approval of stability reports
  • Support for regulatory submissions and variations in close cooperation with global and local stakeholders
  • Creating, Review and approval of compliance records (Changes, complaints, deviation) and other documents
  • Conduct, execute and document impact assessments and investigations
  • Providing overview about Quality Performance of CMOs (CPV) and product related data
  • Support analytical method transfer to external analytical service providers/CMOs
  • Providing overview on deviations, complaints and follow-up of defined actions for improving Right First Time at CMOs
  • Performing QC-releases for Oral Products

Qualification and experience

  • Bachelor / Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
  • Minimum 5 years overall experience within the pharmaceutical, biotechnology, or medical device industry
  • Experience in Quality Control, Pharm. Manufacturing or Stability Management
  • Experience with software for Quality processes (e.g. Trackwise) and / or for data analysis (e.g. PowerBI, Excel, Minitab)
  • Team player
  • Fluent in English and German in an asset

Preferred Requirements

  • Working experience in different cultures
  • Working experience in Pharmaceutical/Analytical Development
  • Audit experience

CSL Vifor is committed to providing equal employment opportunity for all.

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.

  • Quality Operations Manufacturing Science QC Lead

    vor 4 Wochen

    St. Gallen, Sankt Gallen, Schweiz CSL Vollzeit

    Job Title: Quality Operations Manufacturing Science QCAs a Quality Operations Manufacturing Science QC, you will play a critical role in ensuring product knowledge and providing best support for our Contract Manufacturing Organizations (CMOs) and analytical service providers for external manufactured APIs and Finished Drug Products in the oral portfolio.Key...

  • Quality Assurance Specialist

    vor 2 Wochen

    St. Gallen, Sankt Gallen, Schweiz CSL Vollzeit

    Job Summary We are seeking a Quality Assurance Specialist to join our Quality team in St. Gallen, Switzerland. The ideal candidate will support the local site regarding supplier/third-party qualification status and process, reporting directly to the Head of Supplier Quality Management (CH). Main Responsibilities Execute GxP quality systems audits of...

  • Senior Auditor for Supplier Quality Management

    Vor 6 Tagen

    St. Gallen, Sankt Gallen, Schweiz CSL Vollzeit

    Discover a challenging opportunity as Senior Auditor for Supplier Quality Management with CSL Vifor, a leading global player in iron deficiency and nephrology.Estimated Salary: $120,000 - $180,000 per annum, depending on experience.About the RoleWe are seeking an experienced Senior Auditor to join our Quality team in St. Gallen, Switzerland, supporting the...

  • Quality Assurance Specialist

    vor 3 Wochen

    St. Gallen, Sankt Gallen, Schweiz CSL Vollzeit

    Job SummaryWe are seeking a highly skilled Senior Auditor Quality Systems to join our Quality team. The ideal candidate will have a strong background in GxP quality systems, auditing, and supplier management.Main ResponsibilitiesExecute GxP quality systems audits of approved and potential suppliers of raw materials, components, and service providers.Prepare...

  • Senior Auditor External Supplier Quality

    vor 3 Wochen

    St. Gallen, Sankt Gallen, Schweiz CSL Vollzeit

    Job SummaryWe are seeking a highly skilled Senior Auditor External Supplier Quality to join our Quality team in St. Gallen, Switzerland. The successful candidate will support the local site regarding supplier/third-party qualification status and process, and will report directly to the Head of Supplier Quality Management (CH). We offer a flexible and hybrid...

  • Supply Chain Specialist

    vor 4 Wochen

    St. Gallen, Sankt Gallen, Schweiz VAT Vollzeit

    Unlock Your Potential with VATWe are seeking a highly skilled Supply Specialist to join our Indirect Purchasing team in Haag, Switzerland.As a key member of our team, you will work closely with Category Management to determine what to buy and where. Your focus will be on quality, cost, and on-time delivery, with the highest priority on meeting our internal...

  • Supply Chain Specialist

    vor 3 Wochen

    St. Gallen, Sankt Gallen, Schweiz VAT Vollzeit

    Unlock Your Potential with VATWe are seeking a highly skilled Supply Specialist to join our Indirect Purchasing team in Haag, Switzerland.As a key member of our team, you will work closely with Category Management to determine what to buy and where. Your focus will be on quality, cost, and on-time delivery, with the highest priority on meeting our internal...

  • Supply Chain Specialist

    vor 3 Wochen

    St. Gallen, Sankt Gallen, Schweiz VAT Vollzeit

    Be Part of Our Dynamic Team!VAT, a leading international developer, manufacturer, and supplier of high-performance high-end vacuum valves and vacuum sealing technology, is seeking a talented Supply Specialist to join our Indirect Purchasing team.As a key member of our team, you will work closely with Category Management to determine what to buy and where....

  • Head of Quality Assurance und FvP Naturstoffe

    vor 2 Wochen

    St. Gallen, Sankt Gallen, Schweiz gloor&lang AG Vollzeit

    Qualitätsführung im UnternehmenUnser Kunde, ein innovativer Hersteller von natürlichen Arzneimitteln, sucht eine motivierte Persönlichkeit für die Leitung der Abteilung Quality. In dieser Rolle führen Sie Ihr Team in QA und QC von rund 10 Mitarbeitenden und tragen zur fachlichen und persönlichen Weiterentwicklung des Teams bei.Ihre Aufgaben:Sie...

  • DevOps Implementation Specialist

    vor 2 Wochen

    St. Gallen, Sankt Gallen, Schweiz dentsu Vollzeit

    About the RoleMerkle, a dentsu company, is seeking a skilled DevOps Implementation Specialist to join our team. As a DevOps Implementation Specialist, you will be responsible for deploying and operating modern, scalable systems in the finance sector.Key ResponsibilitiesDeploy and operate modern, scalable systems in the finance sector.Provide troubleshooting...

  • Process Engineer

    vor 4 Wochen

    St. Gallen, Sankt Gallen, Schweiz VAT Vollzeit

    Join VAT's Team of InnovatorsVAT is seeking a highly skilled Process Engineer to join our team in Haag, Switzerland. As a Process Engineer - NPI Machining Specialist, you will be responsible for collaborating with project teams to develop and introduce new parts, focusing on improving and refining the processes involved.Your Key ResponsibilitiesConduct NPI...

  • Global Supply Chain Specialist

    vor 3 Wochen

    St. Gallen, Sankt Gallen, Schweiz VAT Vollzeit

    Unlock Your Potential in a Dynamic Supply Chain RoleVAT is seeking a skilled Global Supply Chain Specialist to join our team in Haag, Switzerland. As a trusted expert and business partner, you will execute and fulfill all assigned orders in regards to Quality, Delivery, and Cost, inline with the business requirements of business units, sales, and...

  • Vacuum Valve Development Specialist

    vor 1 Woche

    St. Gallen, Sankt Gallen, Schweiz VAT Vollzeit

    Our Vision for InnovationVAT has been a leading developer, manufacturer, and supplier of high-performance vacuum valves and vacuum tightness technology for over 50 years.As a member of our SEMI business unit, you will work on developing vacuum valves and systems for the semiconductor industry.Our products are key elements for the next generation of computer...

  • Senior Auditor External Supplier Quality

    vor 4 Wochen

    St. Gallen, Sankt Gallen, Schweiz CSL Vollzeit

    About the RoleWe are seeking a Senior Auditor External Supplier Quality to join our Quality team in St. Gallen, Switzerland. As a key member of our team, you will be responsible for executing GxP quality systems audits of approved and potential suppliers of raw materials, components, and service providers for our CSL Sites.Main AccountabilitiesExecute...

  • Postdoctoral Researcher in Social Sciences, Horizon Europe Project

    vor 4 Wochen

    St. Gallen, Sankt Gallen, Schweiz University of St Vollzeit

    Your TasksContribute to the development of a centralised Data Cube Ecosystem within the NOSTRADAMUS Horizon Europe project, focusing on multifunctional open-source digital applications for key actors in the EU agricultural sector.Engage in co-creation processes with experts from various disciplines, including big data analytics, ecosystem modelling, and soil...

  • Senior Semiconductor Application Specialist

    vor 4 Wochen

    St. Gallen, Sankt Gallen, Schweiz VAT Vollzeit

    Transforming Semiconductor InnovationVAT is seeking an experienced Application Manager to drive technology and product development roadmaps for its Semiconductor division. The ideal candidate will have a proven record of solving leading-edge technical challenges and possess strong business acumen.Your Key ResponsibilitiesRepresent the technical interface...

  • Postdoctoral Researcher in Social Sciences

    vor 3 Wochen

    St. Gallen, Sankt Gallen, Schweiz University of St Vollzeit

    Your TasksThe successful candidate will:Contribute to the development of a centralised Data Cube Ecosystem within the NOSTRADAMUS Horizon Europe project, which aims to support informed and sustainable decision making in the EU agricultural sector.Engage in co-creation processes with experts from various disciplines, including big data analytics, ecosystem...

  • Kitchen Support Specialist

    vor 2 Monaten

    St. Gallen, Sankt Gallen, Schweiz beBee Professionals Vollzeit CHF 50'000 - CHF 70'000

    Job Description:We are seeking a highly motivated and skilled Commis de Cuisine to join our culinary team at beBee Professionals in Sankt Gallen, Switzerland.Key Responsibilities:Assist the head chef in preparing and presenting high-quality dishes.Perform mise en place for daily kitchen operations.Maintain high standards of hygiene and quality.Prepare and...

  • Senior Auditor External Supplier Quality

    vor 4 Wochen

    St. Gallen, Sankt Gallen, Schweiz CSL Vollzeit

    Job SummaryWe are seeking a highly skilled Senior Auditor External Supplier Quality to join our Quality team in St. Gallen. The successful candidate will support the local site regarding supplier/third-party qualification status and process, and will report directly to the Head of Supplier Quality Management (CH).Main ResponsibilitiesExecute GxP quality...

  • Senior Auditor External Supplier Quality

    vor 2 Wochen

    St. Gallen, Sankt Gallen, Schweiz CSL Vollzeit

    Main AccountabilitiesExecute GxP quality systems audits of approved and potential suppliers of raw materials, components, and service providers for CSL sites.Prepare audit reports and assign levels of compliance to each observed action based on established criteria.Evaluate supplier corrective action plans to ensure plans satisfactorily address the...