QA Manager
Vor 5 Tagen
Quality Management für Pharma Marktzulassungen Schweiz
Unser Kunde ist ein Beratungs- und Dienstleistungsunternehmen im Raum Basel. Nationale und internationale Pharma- und Healthcare-Unternehmen werden zu regulatorischen und qualitätstechnischen Fragen beraten und aktiv betreut. Das QA Team mit Sr. Consultants sucht Sie als neue deputy FvP für zahlreiche Kunden.
Sie wollen:
- Die umfangreichen Arzneimittelportfolios verschiedener Kunden betreuen, inkl. lokaler Marktfreigabe
- Qualitätsvereinbarungen mit Kunden und Partnern mitgestalten und prüfen
- Product Quality Reviews evaluieren
- Behördeninspektionen und Kundenaudits unterstützen und begleiten
Ihre Aufgaben:
- Pflege und Weiterentwicklung des Qualitätsmanagementsystems sowie Mitarbeit bei Digitalisierungsprojekten
- Bearbeitung von Qualitätsmängeln, Abweichungen, CAPAs in Zusammenarbeit mit FvP, Team, Kunden und Partnern
- Koordination des Change Control Managements
- Durchführen von externen GDP-Audits und Selbstinspektionen
- Stellvertretung der fachtechnisch verantwortlichen Person
Ihre Erfahrungen:
- Hochschulabschluss aus den Naturwissenschaften
- 5 Jahre Berufserfahrung im Bereich Quality Management Schweiz
- Kenntnisse Marktfreigabe Arzneimittel in der Schweiz, gerne schon in deputy FvP Rolle
- Interesse an selbstständiger und abwechslungsreicher Projektarbeit in einem Dienstleistungsunternehmen
- Freude an der Optimierung von Arbeitsprozessen
- Affinität für qualitätsrelevante, regulatorische und rechtlichen Zusammenhänge
- Sehr gute schriftliche und mündliche Sprachkenntnisse in Deutsch und Englisch, Kenntnisse in Französisch von Vorteil
Sie sind aufgeschlossen, selbständig und gewissenhaft. Ihre Arbeitsweise ist organisiert und strukturiert und Sie können in anspruchsvollen Situationen geordnet vorgehen und Prioritäten setzen. Unser Kunde sucht eine Dienstleister-Persönlichkeit mit starkem Fachhintergrund und bestimmter, klarer Kommunikation.
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