Quality System Archiv Manager
vor 4 Wochen
We make it GmbH ist ein national in der Schweiz agierendes Unternehmen, welches dank langjähriger und erfolgreicher Erfahrung über eine hohe Kompetenz im Personaldienstleistungsbereich verfügt. Konzentration der Vermittlertätigkeiten auf die Kernbereiche Industrie, Technik, Büro/Administration, Engineering, Pharma und Informatik. Die We make it GmbH stellt höchste Ansprüche an Qualität, Ethik und Diskretion.
Für unseren Kunden, die Firma F. Hoffmann La Roche mit Sitz in Kaiseraugst, suchen wir eine/n
Quality System Archiv Manager (m/w/d)
Beschreibung
Innerhalb von Drug Product Manufacturing KAU/BS betreibt Quality Systems ein Zentralarchiv, welches für die Verwaltung von physischen Dokumenten verantwortlich ist. Dies beinhaltet das Empfangen von Dokumenten
aus verschiedenen Produktionseinheiten und Supportfunktionen, die anschliessende Verwahrung im Archiv vor Ort wie auch die Auslagerung in ein externes Archiv.
Der perfekte Kandidat ist ein: Kommunikative Mitarbeiter/in, welcher seine Arbeit proaktiv plant und ausführt. Der/die Kandidatin hat Erfahrungen im GMP Bereich, kann Dokumente, Abweichungen und Changes bearbeiten und hat Freude an physischer Arbeit im Archiv sowie in der Kundenbetreuung der verschiedenen zu betreuenden
AufgabenVerwaltung des Zentralarchivs für den Standort Drug Product Manufacturing KAU/BS
GMP-konforme Verwaltung, Ablage und Archivierung von Dokumenten
Nutzung des Archivierungssystems UnIS zur Archivierung und Verwaltung von Dokumenten
Sicherstellung des Vernichtungsprozesses am Ende der festgelegten Aufbewahrungsdauer
Koordination der Auslagerung von archivierten Dokumenten an externe Archivanbieter
Erstellung lokaler Standardarbeitsanweisungen (SOPs) für Quality Systems
Bearbeitung von Abweichungen und Changes für das Zentralarchiv
Förderung der kontinuierlichen Verbesserung und Harmonisierung von Prozessen und Systemen in Zusammenarbeit mit verschiedenen Schnittstellen
QualifikationKaufmännische, technische oder naturwissenschaftliche Ausbildung
3+ Jahre Erfahrungen im GxP Umfeld
3+ Jahre Erfahrungen mit Archiv- und Dokumentationsprozessen
Umgang mit Office / Google Softwarelösungen
Deutsch fliessend in Wort und Schrift, Englisch von Vorteil
Gute Zusammenarbeit und Kommunikation, Teamfähigkeit, proaktives Arbeiten
Nice to haves
Erfahrungen mit GMP-Systemen wie Track Wise, Veeva oder ähnliches
Arbeitszeiten
Standard Mo - Fr
Sind Sie interessiert?
Dann freut sich Herr Andre Amstad auf Ihre vollständigen Bewerbungsunterlagen (Lebenslauf, Arbeitszeugnisse und Ausbildungsnachweise)
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