QA Manager

vor 4 Wochen


Göttingen, Niedersachsen, Deutschland NextPharma Vollzeit
Job Description

Wir suchen einen erfahrenen QA Manager, der sich auf die Durchführung und Weiterentwicklung des jährlichen Product Quality Review (PQR) spezialisiert hat.

Aufgaben:
  • Organisation und Durchführung des PQR entsprechend des EU-GMP-Leitfadens
  • Internes Management der PQRs durch enge Zusammenarbeit mit den Fachabteilungen im Unternehmen und Auswertung von Datenbanken
  • Zusammenfassung von Abweichungsberichten, Reklamationen, OOS-Ergebnissen
  • Analysieren von Daten in Bezug auf Trends
  • Definition von CAPAs
  • Externes Management der PQRs durch Absprachen mit Kunden und Mitwirken an den relevanten vertraglichen Vereinbarungen
  • Pflege und Schulung der PQR-SOP und zugehörigen Dokumenten
  • Präsentation des PQR in Kunden- und Behördenaudits
  • Unterstützung unseres Teams Qualitätssicherung im Bereich Auditmanagement und GMP-gerechte Dokumentation
Was bieten wir Ihnen?
  • Passgenaues On-Boarding
  • 30 Urlaubstage sowie Urlaubsgeld
  • Betriebliche Altersvorsorge
  • Mitarbeiter-Events und betrieblicher Sport
  • Weiterbildungen bei der internen NextAcademy
  • Mitarbeiter-Rabatte
Was sollten die Bewerber/-innen mitbringen?
  • Abrobation als Apotheker/in
  • Berufserfahrung in der pharmazeutischen Industrie sowie gute Kenntnisse im GMP-Regelwerk mit Fokus auf qualitätsrelevante Themen sind von Vorteil
  • Erfahrungen im Bereich PQR sind erwünscht aber keine Voraussetzung
  • Statistische Kenntnisse sind von Vorteil aber keine Voraussetzung
  • Analytisches Denken und strukturierte Arbeitsweise
  • Selbständige Arbeitsweise und hohe Eigenmotivation
  • Kommunikations- und Teamfähigkeit
  • Sicherer Umgang mit MS-Office-Paket, insbesondere Word und Excel
  • Sehr gute Englischkenntnisse in Wort und Schrift
Wir freuen uns auf Ihre Bewerbung
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