Sr Spec QA Aseptic Expert

vor 2 Wochen

Schaffhausen, Schaffhausen, Schweiz Johnson & Johnson Innovative Medicine Vollzeit CHF 100'000 - CHF 120'000 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
Senior Specialist QA Aseptic Expert & Oversight, 80-100%, on-site, befristet auf 2 Jahre
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
  • Leitung/ Vorantreiben von zugewiesenen Projekten

Wen Wir Suchen

  • Berufsausbildung oder mehrjährige Erfahrung in der Pharma- oder Lebensmittelindustrie
  • Kenntnisse der aseptischen Herstellung sowie Erfahrung in eine Qualitätsrolle sind 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
  • Gute Englischkenntnisse in Wort und Schrift

Der Vertrag ist auf 2 Jahre befristet, was Flexibilität und die Möglichkeit zur Weiterentwicklung bietet.

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

Required Skills
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

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