Quality Audit

vor 3 Wochen

Sankt Gallen, Schweiz TN Switzerland Vollzeit

Social network you want to login/join with:

Quality Audit & Supplier Qualification, St. GallenClient:

CSL

Location:

St. Gallen

Job Category:

Other

Job Reference:

f2c9b3c98fc3

Job Views:

14

Posted:

19.02.2025

Expiry Date:

05.04.2025

Job Description:

Title: Auditor (Senior), External Supplier Quality

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

  1. 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.
  2. 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.
  3. Responsible for interpreting and making decisions based on company policies and procedures, regulatory agencies, local, state, federal and international regulations.
  4. 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.
  5. Bring/maintain the suppliers/third parties to the expected level of compliance.

Key Tasks

  1. Local Point of Contact for External Supplier Quality (ESQ) organization.
  2. Plan, execute and follow-up assigned audits.
  3. Revise, edit and route for signature Quality Agreements as assigned.
  4. Supplier-related complaints follow-up (tracking, investigation completion and proper CAPA plan).
  5. Supplier improvement plans where applicable.

Your Profile

  1. Requires a four-year degree in a relevant business or science, or equivalent education and experience.
  2. Minimum of 3 years’ experience in a GxP environment in the pharmaceutical industry.
  3. Thorough understanding of required regulations including FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.
  4. Industry and auditing knowledge (internal and external), with relevant evidence.
  5. Must be comfortable working in a global, matrix organization.
  6. Fluent in English (written and spoken). Other languages (German, French) would be an asset.

Preferred Requirements

  1. 3-5 year-experience in a QA role in a pharmaceutical company, including global and/or regional audit responsibility.
  2. Knowledge of Quality Systems and Supplier Management.
  3. Knowledge and experience in sterile and non-sterile product manufacturing, biological processes, laboratory operations, distribution.
  4. Demonstrated ability to interact with and gain the support of senior management, global partners, and cross-functional teams.
  5. 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 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.

#J-18808-Ljbffr

  • Quality Audit Management Lead

    vor 1 Woche

    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 2 Wochen

    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 Engineering Specialist

    vor 3 Wochen

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    Quality Engineering Specialist, MittellandClient:EPM ScientificLocation:-Job Reference:fe35a311ef61Job Views:4Posted:03.03.2025Expiry Date:17.04.2025Job Description:Key Responsibilities:Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems.Supports the development, reviews, and releases...

  • Lead Auditor

    vor 3 Wochen

    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 Engineer

    vor 3 Wochen

    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...

  • Head of Quality

    vor 3 Wochen

    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 Manager Distribution

    vor 3 Wochen

    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...

  • QM/Quality Engineer

    vor 1 Tag

    St. Gallen, Sankt Gallen, Schweiz EPM Scientific Vollzeit

    Direct message the job poster from EPM ScientificRecruitment Consultant - Medical Device - QA/RA and R&DI am on the search for a Quality Engineer for a key client of mine in Switzerland. The ideal candidate must meet the below requirements and expertise.Key Requirements:Proven experience with injection moulding and medical devices.Strong understanding of...

  • Audit Lead

    Vor 5 Tagen

    St. Gallen, Sankt Gallen, Schweiz CSL Plasma Inc. Vollzeit

    We are looking for a highly skilled Audit Lead to join our team in St. Gallen, Switzerland.The successful candidate will have extensive experience in auditing quality systems in the pharmaceutical industry and will be responsible for ensuring compliance with regulatory requirements.Responsibilities:

  • Quality Systems Manager

    Vor 5 Tagen

    St. Gallen, Sankt Gallen, Schweiz CSL Plasma Inc. Vollzeit

    Candidates must have thorough understanding of required regulations, including FDA, PIC/S, and European regulations, as well as strong industry and auditing knowledge.In this role, you will conduct audits of suppliers to ensure compliance with our quality standards.You will work closely with other departments to identify and mitigate risks and develop...

  • Senior Quality Assurance Specialist

    Vor 5 Tagen

    St. Gallen, Sankt Gallen, Schweiz CSL Plasma Inc. Vollzeit

    CSL Plasma Inc. is seeking a Senior Quality Assurance Specialist to support the local site regarding supplier/third-party qualification status and process.The ideal candidate will have at least 5 years of experience in a QA role in a pharmaceutical company, including global and/or regional audit responsibility.Key Responsibilities:

  • Project Quality Manager

    vor 2 Wochen

    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...

  • Quality Assurance Manager/ Supplier Management Oral

    Vor 6 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...

  • Head of Quality

    vor 3 Wochen

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    AufgabenLeitung und Weiterentwicklung aller Bereiche des Qualitätsmanagements mit insgesamt 8 MitarbeitendenWeiterentwicklung der bestehenden Qualitäts-, Sicherheits- und Umweltmanagementsystems in Zusammenarbeit mit der GeschäftsleitungUnterstützung der internen Bereiche wie Operations, Forschung & Entwicklung und Sales über den gesamten...

  • Quality Assurance Manager/ Supplier Management Oral

    Vor 6 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 Operations Manufacturing Science Qc

    Vor 4 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 Expert R&D and Global Engineering

    Vor 5 Tagen

    Sankt Gallen, Schweiz SCHOTT Pharma Schweiz AG Vollzeit

    SCHOTT is a leading international technology group in the areas of specialty glass and glass-ceramics. With more than 130 years of outstanding development, materials and technology expertise we offer a broad portfolio of high-quality products and intelligent solutions. SCHOTT is an innovative enabler for many industries, including the home appliance,...

  • Head of Global Quality Management

    vor 1 Woche

    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...

  • Quality Management Professional

    Vor 5 Tagen

    St. Gallen, Sankt Gallen, Schweiz SCHOTT Vollzeit

    Your ResponsibilitiesMaintain and develop the R&D QMS, ensuring compliance with ISO 15378 and ISO 13485.Manage the R&D CAPA process.Perform internal audits according to ISO 15378 and ISO 13485.Drive continuous improvement within R&D and on its interfaces.You will work closely with cross-functional teams to ensure seamless communication and collaboration.

  • Lead Auditor

    Vor 4 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...