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Quality Systems Specialist ITOT

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Basel, BS, Switzerland
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The posting

--- base: / meta-keywords: meta-viewport: width=device-width, initial-scale=1.0 title: Quality Systems Specialist ITOT ---

Quality Systems Specialist ITOT ===============================

Quality Systems Specialist ITOT:* Herstellungsanalytik / SingleLIMS / Qualitätskontrolle / GMP / Labware / IPC/ QC / Pflege von Stammdaten / Product Lifecycle / *English / Deutsch

Hintergrund:

Die Gruppe 'Laboratory \& Manufacturing Systems Support' der Abteilung ITOT in Basel (Arbeitsort ist Kaiseraugst \& Basel) ist für den 1st Level Support der MAR (make, assess, release) relevanten Qualitätssysteme Batch Release Hub, MPC und SingleLIMS und für die Pflege der Masterdaten in SingleLIMS bei Tech\-Transfers und während Product Lifecycle Aktivitäten verantwortlich.

In dieser Funktion stellen Sie mit Ihren Kollegen sicher, dass die Stammdaten die behördlichen Anforderungen abdecken sowie die Arbeitsabläufe der Kunden reflektieren. Durch den 1st Level Support tragen Sie entscheidend dazu bei, die Lead Time hinsichtlich

der Produktion und Freigabe von Produkten einzuhalten .

Der oder die perfekte Kandidat:in:

Die perfekte Person für diese Stelle verfügt über ein abgeschlossenes naturwissenschaftlich\-technisches Studium (z. B. Pharma oder Chemie) sowie 1 bis 3 Jahre Berufserfahrung in der pharmazeutischen Qualitätskontrolle oder Produktion unter GMP\-Bedingungen. Gesucht wird fundierte Praxiserfahrung in der Stammdatenpflege \- idealerweise mit LIMS wie Labware \- und der pharmazeutischen Analytik (IPC/QC), um zuverlässig den 1st Level Support zu übernehmen. Neben einer selbstständigen, strukturierten Arbeitsweise unter engen Timelines zeichnen eine hohe Serviceorientierung, starke Kommunikationsfähigkeit und fließendes Deutsch (C1\) das Profil aus. Von Vorteil sind Englischkenntnisse, Erfahrung im Bereich Business Analytics sowie Vertrautheit mit \-internen Systemen.

Aufgaben \& Verantwortlichkeiten:

  • 1st Level Support für SingleLIMS bei stammdaten\-relevanten Anfragen im eigenen Verantwortungsbereich
  • Neuaufnahme, Anpassung und Review von Stammdaten und Methoden entsprechend den Bedürfnissen der Kunden bzw. der behördlichen Anforderungen
  • Review von Probenahmepläne und Kommunikation von Requirements an das Business
  • Erstellen und Aktualisieren von Konzepten, Arbeitsanweisungen (SOPs) und anderen relevanten GMP\-Dokumenten
  • Schnittstelle zwischen dem Kunden (Business) und global IT (Entwickler, 2nd/3rd Level Support)

Must Haves:

  • Voraussetzung für die abwechslungsreiche Stelle ist ein abgeschlossenes Studium in den relevanten Bereichen (z.B. Pharma, Chemie, Verfahrenstechnik)
  • Mindestens 1\-3 Jahre Berufserfahrung im GMP Umfeld (vorzugsweise in den Bereichen Produktion oder Qualitätskontrolle)
  • Praxiserfahrung im Bereich der pharmazeutischen Herstellungsanalytik (IPC / QC)
  • Erfahrung mit der Pflege von Stammdaten im GMP Umfeld z.B. mit LIMS (Labware), MES, ERP
  • Selbstständige, strukturierte, und proaktive Arbeitsweise, präzise Arbeit unter strengen Timelines und multiplen parallelen Aufgaben
  • Kommunikative und organisatorische Fähigkeiten und ein selbstsicheres Auftreten
  • Hohe Kunden\- / Serviceorientierung
  • Sehr gute Deutsch Kenntnisse in Wort und Schrift (C1\)

Nice to Haves:

  • Grundkenntnisse von internen Systemen und Projektmanagement sind von Vorteil
  • Erfahrung im Bereich Business Analytics im GMP Manufacturing oder QC Umfeld
  • Englischkenntnisse in Wort und Schrift

Reference Nr.: 925307 : Quality Systems Specialist ITOT Industrie: Pharma Location: Basel oder Kaiseraugst Pensum: 100% Start: ASAP(01\.12\.2026\) Duration: 12 \+ Months Deadline: 13/09/2026

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs\[at\]itcag\[dot\]com.

Contact us for more information about our company, our positions, or our attractive payroll\-only program: .

About us:

ITech Consult is an ISO 9001:2015\-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.

* ITech Consult AG

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* ITech Consult AG

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