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Open nowPosted 48 days ago

Qualifizierungsingenieur im Bereich Drug Substance

job-room.ch86,007 open roles

Where
Basel Stadt, Switzerland
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Your applicationOpen nowQualifizierungsingenieur im Bereich Drug Substancejob-room.ch · Basel Stadt, Switzerland

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on job-room.ch's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

7.9% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.9%7 days
  4. 14.2%14 days
  5. 34.1%30 days
This job: posted 48 days ago

The posting

Qualifizierungsingenieur im Bereich Drug Substance #

(m/w/d)

freiberuflich/in temporärer Festanstellung für ein Projekt

Basel Stadt

Startdatum: sofort

Referenznummer: 890331/1

Aufgaben ###

  • Erstellen von Konzepten, QPP (Qualifizierung Projekt Plan) resp. VMP (Validierungs Master Plan)
  • Erstellen von Qualifizierungs-/Validierungsplänen /-report für alle Phasen gemäß internem Qualitäts-System
  • Durchführung von Qualifizierungen/Validierungen in allen Phasen gemäß internem Qualitäts-System
  • Bewertung von technischen Änderungen an Anlagen hinsichtlich Einfluss auf den qualifizierten Zustand und selbstständige Abarbeitung von Requalifizierungsaktivitäten
  • GMP-konforme Dokumentation der durchgeführten Arbeiten und Zusammenfassung der aufgetretenen Abweichungen
  • Erarbeitung von Lösungsvorschlägen zu den aufgetretenen Abweichungen
  • Einarbeitung in eine elektronische Qualifizierungs- und Validierungssoftware

Profil ###

  • Abschluss in einem Natur- / Ingenieurwissenschaftlichen Studiengang oder relevante Berufserfahrung
  • Solide Berufserfahrung im Qualifizierungsprozess
  • Praktische Berufserfahrung mit Qualifizierungen/CSV verschiedener Arten von Anlagen/Systemen und Räumen/Medien
  • Fundierte Erfahrung im GMP-Bereich mit vertieftem Verständnis für Qualitätssysteme und dem schlanken Umsetzen von GMP Anforderungen
  • Gute Kenntnisse in der Thematik -Data Integrity"
  • Sehr gute Deutschkenntnisse in Wort und Schrift sowie gute Englischkenntnisse

Benefits ###

  • Abwechslungsreiche Tätigkeit in einem renommierten Unternehmen
  • Betreuung im gesamten Bewerbungsprozess
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