Quality Assurance Manager
vor 3 Wochen
Auf einen Blick
Für den Aufbau unseres neuen Bereiches «Aseptic Manufacturing Services» suchen eine erfahrene Persönlichkeit mit Kenntnissen in der Equipment-Qualifizierung und CSV im GxP-Pharmaumfeld. In dieser Funktion sind Sie unter anderem für die Implementierung und Umsetzung der Qualifizierungsstrategie für unsere Prozessequipments verantwortlich. Auch das Begleiten und Koordinieren von FAT's sowie die Erstellung der notwendigen Qualifizierungsdokumentation gehören zum Aufgabengebiet dazu. Sie erwartet ein dynamisches und engagiertes 12-köpfiges Team. In dieser Rolle tragen Sie entscheidend zur Realisierung unserer Projekte bei.
Aufgaben
- Verantwortlich für die Entwicklung und Implementierung von neuen Qualifizierungsstrategien und -methoden
- Sicherstellung und Erhalt des qualifizierten Status der zugewiesenen Bereiche und Equipments
- Abgleich von Qualifizierungsstrategien mit Kunden zum Aufbau von Business Needs
- Verantwortlich für die Planung und Durchführung von Qualifizierungsmassnahmen in Übereinstimmung mit den geltenden Regularien (cGMP) inkl. Betreuung von FAT's
- Verantwortlich für die Planung und Durchführung der vorbeugenden Instandhaltung inkl. Support bei der Erstellung Wartungsplänen
- Implementierung von Optimierungen und Verbesserungen im Verantwortungsbereich
Hardskills
- Abgeschlossenes Studium in einem Fachbereich (Pharma-, Verfahrens-, Elektrotechnik, Biologie, Maschinenbau oder Chemie)
- Erfahrung im GMP-Umfeld (idealerweise in der Qualifizierung, Steril-, ATMP-Produktion oder CSV)
- Solide MS-Office Kenntnisse sowie Kenntnisse in Kneat von Vorteil
- Verhandlungssichere Deutsch- und Englischkenntnisse
Softskills
- Freude an der Arbeit im Team
- Lösungsorientiertes Denken
- Hoher Qualitätsanspruch
- Offene Kommunikation
- Kompetenter Auftritt gegenüber Kunden und Stakeholdern
- Präzise, strukturierte und zuverlässige Arbeitsweise
Wir bieten
- Eine offene und kollegiale Unternehmenskultur
- Freiraum für Ideen
- Teilnahme an Sport und Freizeitangeboten
- Förderung durch Weiterbildung, insbesondere an unserer SKAN Academy
- Intensive und joborientierte Einarbeitung
- Kurze Entscheidungswege und flache Hierarchien
- Offene Kommunikationspolitik
- 5 Wochen Ferien und Möglichkeit auf weitere Ferientage
Bei Fragen wenden Sie sich bitte an Andrea Scheurmann.
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