Specialist QA Aseptic Expert

vor 2 Wochen

Schaffhausen, Schaffhausen, Schweiz Johnson & Johnson Innovative Medicine Vollzeit CHF 80'000 - CHF 100'000 pro Jahr

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

Specialist QA Aseptic Expert & Oversight, 80-100%, on-site

Zu den Haupttätigkeiten gehören unter anderem:

  • Quality Oversight des aseptischen Produktionsbereichs vor Ort mit Fokus auf: aseptische Prozesse, Umgebungs- und Utilitiesmonitoring, Verhalten im Reinraum, Einkleiden und Desinfektion sowie Unterstützung in anderen Bereichen

  • Zeitgerechte Auswertung von Beobachtungen im Rahmen der Quality Oversight

  • Verantwortlichkeit für Qualifizierung von Mitarbeitern im aseptischen Bereich

  • Identifizierung von Risiken sowie Verbesserungspotentialen im aseptischen Bereich hinsichtlich Kontaminationskontrolle und aktive Umsetzung entsprechender Initiativen in enger Zusammenarbeit mit der Produktion, Qualitätsabteilung und dem Management

  • Kontrolle und Sicherung der Prozesse in der Pharmaproduktion unter Einhaltung aller GMP-relevanten Weisungen und Vorschriften

  • Koordination und Mithilfe bei der Analyse und Dokumentation von Abweichungen

  • Koordination und Mithilfe bei der Festlegung und Umsetzung korrigierender Massnahmen

  • Erstellung, Bearbeitung und Approval von Dokumenten (z.B. SOPs, WIs, MBRs) im TruVault-System

Wen wir suchen:

  • Berufsausbildung oder mehrjährige Erfahrung in der Pharma- oder Lebensmittelindustrie

  • Kenntnisse der aseptischer Herstellung ist eine Voraussetzung

  • Schichtarbeit im 3-Schichtbetrieb

  • Bereitschaft zu gelegentlichen Wochenendeinsätze

  • Pro-Aktive und exakte Arbeitsweise

  • Sehr gute Kommunikationsfähigkeiten

  • Team Player

  • Gute IT-Anwenderkenntnisse

  • Sehr gute Deutschkenntnisse

  • Grundlegende Englischkenntnisse in Wort und Schrift

Wenn Sie sich für diese spannende Aufgabe in einem international führenden Gesundheitsunternehmen interessieren, freuen wir uns auf Ihre vollständige Bewerbung

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