Equipment Specialist

Vor 2 Tagen


Basel, Schweiz Healthcare Businesswomen’s Association Vollzeit

Job Description Summary

Ausführung der zugewiesenen Aufgaben und Tätigkeiten in der biopharmazeutischen Produktion unter Einhaltung der relevanten GMP-, Arbeitssicherheits- und Umweltrichtlinien.
Operative Routinetätigkeiten um den Herstellprozess fachgerecht durchzuführen und die zeitgerechte Bereitstellung von Wirkstoff in korrekter Qualität und Quantität zu ermöglichen.

Job Description

  1. Mitarbeit im biopharmazeutischen Herstellungsprozess.
  2. Ausführung aller zugewiesenen Tätigkeiten unter Einhaltung der gültigen GMP-, Arbeits-, Betriebs-, Umwelt- und Sicherheitsanweisungen und –richtlinien.
  3. Anleitung von neuen Mitarbeitern während des on-the-job Trainings / Einarbeitungszeit.
  4. Verantwortliche Durchführung einzelner Prozessstufen (Vorbereitung, Durchführung, Abschluss).
  5. Ordnungsgemäße und zeitgerechte Reinigung, Vorbereitung und Sterilisierung der Produktionsgeräte und Produktionsräume.
  6. Durchführung von zugewiesenen Produktionsservicetätigkeiten (z.B. SAP-Buchungen, Dokumentenvorbereitung und –prüfung, Unterstützung bei Wartungsarbeiten).
  7. Probenzug, Aliquotierung, Verteilung und Durchführung von ln-Prozesskontrollen.
  8. Durchführung des delegierten Umgebungsmonitorings für Reinräume und der delegierten Bemusterung von Reinstwasser und Reindampf.
  9. Organisation von Sofortmaßnahmen im Störungsfall, Melden von Auffälligkeiten an den Vorgesetzten.
  10. Exzellente Dokumentation der Tätigkeiten gemäß GMP-Vorschriften.
  11. Einsatz für kontinuierliche Verbesserung.
  12. Ordnungsgemäßer Umgang mit biologischen und chemischen Substanzen in der Produktionsanlage.
  13. Bereitschaft zur kontinuierlichen Verbesserung und Schwachstellenanalyse.
  14. Teilnahme an allen für die Stelle relevanten Schulungen, Pflege der entsprechenden Trainingsnachweise.
  15. Voranbringen und Erhaltung eines HSE gerechten Umfelds: Melden von Beinahe-Unfällen.
  16. Zeitweise Einsätze am Wochenende/Feiertagen und Bereitschaftsdienst nach Plan wenn erforderlich.

Skills Desired

  • Good Documentation Practice
  • Knowledge of GMP
  • Lean Manufacturing
  • Manufacturing Process
  • General HSE Knowledge
  • Cooperation
  • Flexibility
  • Efficiency
  • Biological and Chemical Substance Handling
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