Quality Audit

Vor 2 Tagen

St Gallen, Schweiz CSL Vollzeit

Title: Auditor (Senior), External Supplier Quality

Location: St. Gallen, Switzerland (flexible/hybrid work model)

Type of role: Permanent position

We are looking for a (Senior) Auditor External Supplier Quality to join our Quality team in St. Gallen on a permanent basis. You 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 are offering a flexible and hybrid working model.

Main Accountabilities

· Through remote/desk audit process, executes GxP quality systems audits of approved and potential suppliers of raw materials, components, suppliers and service providers for the CSL Sites. May also perform local Site audits. 

· Prepares audit report and assigns levels of compliance to each observed action based on established criteria. Delivers audit results to suppliers, according to internal CSL timelines. Evaluates supplier corrective action plans to ensure plans satisfactorily address the observation(s) and ensure the corresponding follow-up.

· Responsible for interpreting and making decisions based on company policies and procedures, regulatory agencies, local, state, federal and international regulations.

· Responsible for supplier quality agreements, global and local, which include writing, editing, reviewing, updating and routing the agreements for approvals between CSL Sites, service providers and suppliers. 

Bring/maintain the suppliers/third parties to the expected level of compliance.

Key Tasks

· Local Point of Contact for External Supplier Quality (ESQ) organization.

· Plan, execute and follow-up assigned audits.

· Revise, edit and route for signature Quality Agreements as assigned.

· Supplier-related complaints follow-up (tracking, investigation completion and proper CAPA plan).

· Supplier improvement plans where applicable.

Your Profile

Minimum Requirements

· Requires a four-year degree in a relevant business or science, or equivalent education and experience.

· Minimum of 3 years’ experience in a GxP environment in the pharmaceutical industry.

· Thorough understanding of required regulations including FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.

· Industry and auditing knowledge (internal and external), with relevant evidence.

· Must be comfortable working in a global, matrix organization.

· Fluent in English (written and spoken). Other languages (German, French) would be an asset.

Preferred Requirements

· 3-5 year-experience in a QA role in a pharmaceutical company, including global and/or regional audit responsibility.

· Knowledge of Quality Systems and Supplier Management.

· Knowledge and experience in sterile and non-sterile product manufacturing, biological processes, laboratory operations, distribution.

· Demonstrated ability to interact with and gain the support of senior management, global partners, and cross-functional teams.

· In-depth knowledge of the regulatory environment for the manufacture of drugs.

Are you interested and recognize yourself in the above profile? We are looking forward in 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.

  • 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....

  • Quality Audit Management Lead

    vor 1 Woche

    St. Gallen, Schweiz CSL Behring 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....

  • Quality Audit

    Vor 2 Tagen

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Quality Audit & Supplier Qualification, St. GallenClient:CSLLocation:St. GallenJob Category:OtherJob Reference:f2c9b3c98fc3Job Views:11Posted:22.01.2025Expiry Date:08.03.2025Job Description:Title: Auditor (Senior), External Supplier QualityType of role: Permanent positionWe are looking for a (Senior) Auditor...

  • GMP Quality Assurance Professional

    vor 3 Stunden

    St. Gallen, Sankt Gallen, Schweiz CSL Vifor Vollzeit

    About the RoleWe 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...

  • Quality Assurance Manager/ Supplier Management Oral

    Vor 4 Tagen

    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...

  • Project Quality Manager

    vor 1 Woche

    St. Gallen, Schweiz Onyx Circle AG Vollzeit

    Über unseren Kunden Unser Kunde mit Sitz im Kanton St. Gallen ist in der Entwicklung und Herstellung innovativer sowie hochwertiger Elektronikkomponenten tätig, welche in Elektroautos zum Einsatz kommen. Mit Sitz in der Schweiz investiert die Firma stetig in den hiesigen Standort und ist aktuell dabei, das bestehende Team stark auszubauen. Aus diesem...

  • Lead Auditor

    vor 1 Tag

    Sankt Gallen, Schweiz CSL Plasma Inc. Vollzeit

    Lead Auditor (Senior), External Supplier QualityLead Auditor (Senior), External Supplier QualityWe are looking for a (Senior) Lead Auditor, External Supplier Quality to join our Quality team in St. Gallen on a permanent basis. You will support the local site regarding supplier/third-party qualification status and process and will report directly to the Head...

  • Quality Operations Manufacturing Science Qc

    Vor 2 Tagen

    St. Gallen, Schweiz CSL Behring Vollzeit

    At CSL Vifor we have established a new organizational model for managing important Contract Manufacturing Organization (CMO) partnerships. In this context, we are offering an exciting opportunity for our Quality Operations External API & Oral Products Department as **Quality Operations Manufacturing Science QC Support** Manager**: In this role you will...

  • Quality Assurance Manager/ Supplier Management Oral

    Vor 4 Tagen

    St. Gallen, Schweiz CSL Behring Vollzeit

    We 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...

  • Quality Engineering specialist

    Vor 3 Tagen

    Saint Gallen, Schweiz Pharmiweb Vollzeit

    Proclinical is seeking a Quality Engineering Specialist to join our client's team in Visp, Switzerland. This role focuses on managing quality-related responsibilities for daily qualification activities on technical facilities, equipment, and systems. We are looking for someone who can support the development, review, and release of qualification documents,...

  • Quality Engineer

    Vor 2 Tagen

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    In this role, you will have the opportunity to drive meaningful improvements, collaborate with talented professionals, and contribute to the ongoing success of a global leader in data and energy transmission technologies.Candidate profile:Technical Expertise: In-depth understanding of high-frequency, fiber optic, and low-frequency technologies, including the...

  • Quality Operations Manufacturing Science QC

    Vor 2 Tagen

    St. Gallen, Schweiz CSL Vollzeit

    Quality Operations Manufacturing Science QC Support Manager In this role 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. Furthermore, you will be responsible for the following...

  • Head of Global Quality Management

    Vor 6 Tagen

    St. Gallen, Schweiz LHH Vollzeit

    Werden Sie Teil des hoch angesehenen Teams unseres Kunden als** Head of Global Quality Management (w/m/d)** und präsentieren Sie Ihre Expertise in Standardisierung, internen Audits, Zertifizierungen, Implementierung von Qualitätsmanagementsystemen und Top-Management-Workshops. Diese außergewöhnliche Gelegenheit ermöglicht es Ihnen, in einem dynamischen...

  • Head of Quality

    Vor 2 Tagen

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Responsibilities:Management and further development of all areas of quality management with a total of 8 employeesFurther development of the existing quality, safety and environmental management systems in collaboration with managementSupport of internal areas such as operations, research & development and sales...

  • Quality Engineering specialist, St. Gallen

    vor 1 Tag

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Quality Engineering Specialist, St. GallenClient:Location:Job Category:-Job Reference:61815cbfa1f1Job Views:5Posted:21.01.2025Expiry Date:07.03.2025Job Description:Proclinical is seeking a Quality Engineering Specialist to join our client's team in Visp, Switzerland. This role focuses on managing quality-related...

  • Lead Auditor

    Vor 2 Tagen

    St. Gallen, Schweiz CSL Behring Vollzeit

    For our location in St.Gallen, we are currently looking for a **LEAD AUDITOR**: **RESPONSIBILITIES**: - organize and perform GMP-/ GDP external / internal audits and self-inspection as lead auditor - reflect regulatory standards on audit management process and thirdparty management process - perform third party vendor qualification processes and...

  • Quality Manager Distribution

    Vor 2 Tagen

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:With a diverse portfolio of more than 20 brands sold in approximately 150 countries and territories, Estée Lauder Companies is the global leader in prestige beauty, recognized for its skincare, make-up, fragrances, and hair care products.In Switzerland, Estée Lauder has the main Supply Chain Hub for Travel Retail...

  • Regulatory Compliance Expert

    Vor 3 Tagen

    St. Gallen, Sankt Gallen, Schweiz Pharmiweb Vollzeit

    Responsibilities">Manage quality responsibilities for daily qualification activities on technical facilities, equipment, and systems.Support the development, review, and release of qualification documents.Approve applicable qualification documents.Assess and approve change requests related to the qualified state condition.Ensure deviations are investigated...

  • Qualitätsmanager (M/w/d)

    Vor 3 Tagen

    St. Gallen, Schweiz ROCKEN Vollzeit

    ROCKEN® ist in der digitalen Rekrutierung von Talenten und Experten spezialisiert und zählt alle etablierten Unternehmen aus jeglichen Branchen zu den Partnern. Diese sind national sowie international tätig und bieten dem zukünftigen Talent eine spannende Herausforderung. Mit dem Anspruch, die besten Talente zu rekrutieren, beraten wir unsere Partner...

  • Head of Quality

    Vor 3 Tagen

    St. Gallen, Schweiz FISBA Vollzeit

    Das ist Ihre zukünftige Tätigkeit Leitung und Weiterentwicklung aller Bereiche des Qualitätsmanagements mit insgesamt 8 Mitarbeitenden Weiterentwicklung der bestehenden Qualitäts-, Sicherheits- und Umweltmanagementsystems in Zusammenarbeit mit der Geschäftsleitung Unterstützung der internen Bereiche wie Operations, Forschung & Entwicklung und...