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Specialist Qualification, Validation

vor 5 Monaten


Zwickau, Deutschland Recipharm Vollzeit

Für unseren Standort in 08056 Zwickau suchen wir zur weiteren Unterstützung unseres Teams **ab** **01.01.2023** einen

**Specialist Qualification, Validation & Data Integrity **im Produktionsbereich (m/w/d)**
Als Specialist Qualification, Validation & Data Integrity im Produktionsbereich am Standort Zwickau arbeiten Sie bereichsübergreifend an Themen bezogen auf alle Produktionsanlagen und Prozesse der Bulkherstellung. Ihre Hauptaufgabe ist dabei die Kontrolle der Datenintegrität sowie die Sicherstellung des qualifizierten/ kalibrierten/ validierten Status der zur Herstellung von festen Arzneimitteln benötigten Anlagen und Prozesse.

**Ihre Aufgaben**
- Aufgabenbearbeitung & Wissensvermittlung für Produktionsmitarbeiter im Bereich Data Integrity
- Mitwirkung und Projektkoordination bei (Re-)Qualifizierung von (Neu)Anlagen und (IT-)Systemen in Zusammenarbeit mit angrenzenden Fachabteilungen und Lieferanten
- Eigenständige Verantwortung für die Einhaltung von regulatorisch-relevanten Terminen und GMP-gerechte Dokumentation im Rahmen dieser Aufgaben

**Ihr Profil**
- Abgeschlossene Berufsausbildung als Pharmakant oder einer technischen Fachrichtung mit mehrjähriger Erfahrung im Umfeld der pharmazeutischen Produktion
- Erfahrungen im Umfeld Qualifizierung, Kalibrierung, GMP-gerechter Dokumentation und vertiefte Kenntnisse zu Fragen der Datenintegrität inklusive der zugehörigen Richtlinien und Konzepte
- Technisches Verständnis für Produktionsanlagen, idealerweise nachgewiesen durch konkrete Projekte und Aufgaben zum Wissenstransfer; Kenntnisse zu Produktions
- und Qualitätsstandards, Bereitschaft zur kontinuierlichen Weiterentwicklung (persönlich und fachlich)
- Selbstständige Arbeitsweise, Zielorientierung, Flexibilität, Sachorientierung und Belastbarkeit
- Sicherer Umgang mit MS-Office
- Gute Englischkenntnisse bzw. Bereitschaft diese zu erwerben

**Wir bieten Ihnen**:

- Wertschätzende kollegiale Zusammenarbeit & Gestaltungsspielräume zur Umsetzung Ihrer Ideen
- Wettbewerbsfähige & leistungsgerechte Vergütung
- Vollzeitstelle mit 38,5 Stunden flexibler wöchentlicher Arbeitszeit, 30 Tage Jahresurlaub
- Urlaubsgeld und jährliche Sonderzahlung sowie gesundheitsfördernde Mitarbeiterangebote
- Weitere Leistungen wie z. B. arbeitgeberfinanzierte bAV und private Unfallversicherung

**Haben wir Ihr Interesse geweckt? Wir freuen uns auf Ihre Bewerbung**

Für Ihre Rückfragen steht Ihnen Christina Marschner sehr gern telefonisch unter +49 (0)375 / 322 110 zur Verfügung.

Art der Stelle: Vollzeit