Laboratory Informatics And Csv Specialist

vor 1 Woche

Zürich, Zürich, Schweiz F. Hoffmann-La Roche Ltd Vollzeit

< < ZURÜCKBEWERBENvon: F. Hoffmann-La Roche Ltd At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionLaborinformatik- und CSV SpezialistDie Position«Synthetic Molecules Technical Development" (PTDC) bringt eine breite Palette von Erfahrungen in den Bereichen Drug Substance (DS), Drug Product (DP), Analytical Sciences, Manufacturing Science & Technology mit und arbeitet eng mit wichtigen Partnern in den Bereichen Forschung und frühe Entwicklung (pRED / gRED) sowie globale technische Entwicklung (PTD) zusammen.PTDC ist verantwortlich für die technische Entwicklung unserer Pipeline, die Herstellung von Drug Substance und Drug Product, für klinische Studien sowie für die kommerzielle Herstellung von DS in unserem Fertigungsnetzwerk. In PTDC werden aus synthetischen Molekülen Medikamente. Wir entwickeln robuste, kosteneffiziente Herstellungsprozesse und schaffen Wissen durch Innovation und kontinuierliche Verbesserung in einem Umfeld der Zusammenarbeit.Das Team von System Support & Compliance (PTDC-T) ist verantwortlich für die Bereitstellung der computerisierten Systeme und deren Validierung. Dies beinhaltet eine breite Palette von IT Systemen, Digitalisierungsprojekten sowie die Zusammenarbeit mit Kunden, Roche IT, Engineering, QA und weiteren Abteilungen.Als Laborinformatik- und CSV Spezialist sind sie im Labor- und Herstellungsumfeld tätig und unterstützen die Entwicklungsabteilung im kompletten Lebenszyklus eines Systems. Im Detail bedeutet dies: - Implementation von computerisierten Analyse- und Kontrollsystemen und Durchführung von Computer System Validierungen - Support bei der Evaluation, Planung und der Gerätebeschaffung von computerisierten Systemen in Zusammenarbeit mit den Labor- oder Betriebsfunktionen- Change Management bei den betreuten Computersystemen - Umsetzung der CSV und Roche IT Richtlinien gemäss gültigen Vorschriften im GMP und non-GMP Bereichen- Support der Laborbereiche in Labor IT (GMP & non-GMP)- und CSV Belangen - Maintenance der betreuten Systeme & Erhaltung der Funktionstüchtigkeit über den Lifecycle dieser Systeme- Archivierung und Backup von elektronischen Daten - Hardware und Software Updates/Upgrades - Systemadministration der betreuten Computersysteme und Applikationen- Troubleshooting von computerisierten Systemen- Technische Weiterentwicklung von neuen computerisierten Systemen zur Nutzung im GMP UmfeldIhr Profil:- Abgeschlossene Berufsausbildung im technischen oder pharmazeutischen Bereich (z.B. Chemie- oder Pharmatechnologe/Pharmakant/Chemikant/Automatiker oder ähnliches) mit ausgeprägtem Informatik-Verständnis und Wissen, oder eine Informatik-Ausbildung oder vergleichbares - Erfahrung im GxP und non-GxP Umfeld in der Pharmaindustrie- Erfahrung in der Validierung und Qualifizierung von Computersystemen (CSV) im Pharma Umfeld- Erfahrung der Qualifizierung von Messgeräten von Vorteil - Idealerweise Erfahrung in der Betreuung, Planung, Implementation und Betrieb von computerisierten analytischen Messsystemen und deren Software - Gute Kenntnisse in Windows Betriebssystemen (z.B. Windows 10, 11, Windows Server) - Gute Kenntnisse in Microsoft Office - Gute Kenntnisse der deutschen und englischen Sprache in Wort und Schrift- Positiv denkende, selbständige, initiative und integre Persönlichkeit mit hoher Sozialkompetenz und Flexibilität- Ergebnisorientierte Arbeitsweise, Verantwortungsbewusstsein, und Interesse an kontinuierlicher Prozessverbesserung- Selbstmotivation, Neugier und kontinuierliches Lernen zur Erweiterung der Fähigkeiten- Inklusive Denkweise, Teamarbeit und Freude am Umgang mit Menschen- Mutig und entschlossen, Positionen zu vertreten, auch unangenehme Themen anzusprechen und gegenteilige Ansichten einzufordern- Ein grundlegendes Qualitätsverständnis und die damit einhergehende Arbeitsweise sind Teil ihrer Persönlichkeit- Starker Kundenfokus, faktenbasierte Entscheidungsfindung und deren konsequente UmsetzungBewerbung:Bitte laden Sie Ihre Bewerbung mit Motivationsschreiben, Lebenslauf sowie Ausbildungszeugnissen und Nachweisen hoch.Global Grade –SE5Who we areA healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let's build a healthier future, together.Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more .Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.Roche is an Equal Opportunity Employer.< < ZURÜCKBEWERBEN

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