Lonza
Senior QA Expert(m/w/x)
Full-timeOn-siteSenior
Stein (AR)
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CSCSL Vifor
(Sr.) Specialist, External Supplier Quality(m/w/x)
Sankt Gallen
Full-timeOn-siteSenior
Nejo AI Summary
Facilitating supplier qualification and quality agreements for pharmaceutical products in iron deficiency and nephrology. 5-8 years GxP experience in pharma with thorough regulatory understanding required. Global collaboration with external suppliers.
Requirements
- Degree in relevant business or science, or equivalent education and experience
- Minimum of 5-8 years’ experience in GxP environment in pharmaceutical industry
- Thorough understanding of required regulations including FDA, PiC/S, European regulation, Therapeutics Goods Authority, Canadian Health Authority
- Demonstrated leadership and knowledge of Quality Systems and Supplier Management
- Thorough knowledge of global cGMP regulations and ISO standards
- Demonstrated knowledge of Quality Systems and Supplier Management
- Comfortable working in global, matrix organization
- Fluency in English (written and spoken); other languages (German, French) would be an asset
Tasks
- Act as the local point of contact for the External Supplier Quality organization
- Facilitate supplier enrollment and qualification
- Revise, edit, and route Quality Agreements for signature
- Monitor supplier performance
- Manage supplier-related complaints and deviations, including tracking and investigation completion
- Ensure proper acceptance of CAPA plans
- Develop supplier improvement plans as needed
- Support local site audits upon request
- Make decisions based on company policies and regulatory requirements
- Assist with supplier quality agreement activities and collaborate with team members to meet timelines
- Contribute to the development and maintenance of the global supplier audit schedule and management tools
Work Experience
- 5 - 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Vifor and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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CSCSL Vifor
(Sr.) Specialist, External Supplier Quality(m/w/x)
Sankt Gallen
Full-timeOn-siteSenior
Nejo AI Summary
Facilitating supplier qualification and quality agreements for pharmaceutical products in iron deficiency and nephrology. 5-8 years GxP experience in pharma with thorough regulatory understanding required. Global collaboration with external suppliers.
Requirements
- Degree in relevant business or science, or equivalent education and experience
- Minimum of 5-8 years’ experience in GxP environment in pharmaceutical industry
- Thorough understanding of required regulations including FDA, PiC/S, European regulation, Therapeutics Goods Authority, Canadian Health Authority
- Demonstrated leadership and knowledge of Quality Systems and Supplier Management
- Thorough knowledge of global cGMP regulations and ISO standards
- Demonstrated knowledge of Quality Systems and Supplier Management
- Comfortable working in global, matrix organization
- Fluency in English (written and spoken); other languages (German, French) would be an asset
Tasks
- Act as the local point of contact for the External Supplier Quality organization
- Facilitate supplier enrollment and qualification
- Revise, edit, and route Quality Agreements for signature
- Monitor supplier performance
- Manage supplier-related complaints and deviations, including tracking and investigation completion
- Ensure proper acceptance of CAPA plans
- Develop supplier improvement plans as needed
- Support local site audits upon request
- Make decisions based on company policies and regulatory requirements
- Assist with supplier quality agreement activities and collaborate with team members to meet timelines
- Contribute to the development and maintenance of the global supplier audit schedule and management tools
Work Experience
- 5 - 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Vifor and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
CSL Vifor
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Partner für pharmazeutische Produkte und innovative Therapien in der Eisenmangel- und Nephrologie.
Not a perfect match?
- Lonza
Senior QA Expert(m/w/x)
Full-timeOn-siteSeniorStein (AR) - CSL Vifor
Manager, CMO Quality EMEA(m/w/x)
Full-timeOn-siteManagementSankt Gallen - Lonza
QA Expert - Equipment Qualification & Validation and Data Integrity(m/w/x)
Full-timeOn-siteExperiencedStein (AR) - Lonza
Senior QA Expert – Critical Utilities & Facilities(m/w/x)
Full-timeOn-siteSeniorStein (AR) - Lonza
Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Full-timeOn-siteSeniorStein (AR)