Lonza
Senior QA Expert(m/w/x)
Vollzeitnur vor OrtSenior
Stein (AR)
Neuer Job?Nejo!
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CSCSL Vifor
(Sr.) Specialist, External Supplier Quality(m/w/x)
Sankt Gallen
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 - 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Vifor erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- CSL Vifor
Manager, CMO Quality EMEA(m/w/x)
Vollzeitnur vor OrtManagementSankt Gallen - Lonza
QA Expert - Equipment Qualification & Validation and Data Integrity(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - Lonza
Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
Senior QA Expert – Critical Utilities & Facilities(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR)
CSCSL Vifor
(Sr.) Specialist, External Supplier Quality(m/w/x)
Sankt Gallen
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 - 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Vifor erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
CSL Vifor
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Partner für pharmazeutische Produkte und innovative Therapien in der Eisenmangel- und Nephrologie.
Noch nicht perfekt?
- Lonza
Senior QA Expert(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - CSL Vifor
Manager, CMO Quality EMEA(m/w/x)
Vollzeitnur vor OrtManagementSankt Gallen - Lonza
QA Expert - Equipment Qualification & Validation and Data Integrity(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - Lonza
Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
Senior QA Expert – Critical Utilities & Facilities(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR)