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Specialist Batch Record Review
vor 4 Monaten
**Specialist Batch Record Review (m/w/d) TZ (18,75h/Wo) / 1953€ p.M. + Prämien**
Standort: Biberach an der Riß
Anstellungsart(en): Vollzeit
Arbeitszeit: 37,5 Stunden pro Woche
**Zweck und Ziel der Stelle**
Unser Ziel ist es, Menschen zusammen zu bringen,
die zueinander passen, um gemeinsam Aufgaben
zu lösen.
Für unseren namhaften Kunden in Biberach suchen wir ab sofort, im Rahmen der Arbeitnehmerüberlassung einen Specialist Batch Record Review (m/w/d) TZ (18,75h/Wo).
**Aufgaben, Kompetenzen und Verantwortung**
- Hauptverantwortlich für die Prüfung der Chargendokumentation (Batch Record) auf Vollständigkeit, Richtigkeit sowie Einhaltung von vorgegebenen Prozessgrenzen und GMP-Richtlinien
- Sicherstellung des termingerechten Batch Record Reviews der Chargenherstelldokumentation und Lauf-/Chargenfreigabe
- Expert (m/w/d) für die operative Anwendung der bestehenden Qualitätssysteme und Ansprechpartner (m/w/d) für die Compliance-Beauftragten (m/w/d) der Betriebe und Labore
- Interdisziplinärer Austausch mit Projektbeteiligten (m/w/d) innerhalb von Verbesserungsprojekten qualitätsrelevanter Fragestellungen in die Quality Organisation sowie Entwicklung entsprechender Lösungsansätze
- Erstellung, Überarbeitung und Prüfung von bereichsspezifischen Dokumenten, Plänen und Berichten
- Erstellung und Vorbereitung aller relevanten Dokumente für die Freigabe von Produkten für Qualified Person (QP) (m/w/d)
**Fachliche Anforderungen**
- Abgeschlossene naturwissenschaftliche Ausbildung als Biologie-, Chemielaborant (m/w/d) oder ähnliches mit mehrjähriger Berufserfahrung in der pharmazeutischen Produktion
- Mehrjährige Industrieerfahrung in einem GxP-regulierten Umfeld
- Fundierte Erfahrung bei der Begleitung von Projekten im pharmazeutischen Umfeld und/oder fundierte Erfahrung bei der QA-seitigen Betreuung von Technologietransfers oder Prozessentwicklungen
- Sehr gute EDV-Kenntnisse, insbesondere Microsoft Office, Datenbanken, SAP
- Exzellente Team
- und Kommunikationsfähigkeiten
- Analytisches, risikobasiertes und konzeptionelles Denken und Handeln
- Hohes Maß an Qualitätsverständnis, Eigenverantwortung und Gewissenhaftigkeit
**Arbeitgeberleistungen / Unternehmensangebot**
Wir bieten Ihnen:
- Persönliche Betreuung und kompetente Ansprechpartner
- Übertarifliche Vergütung
- Pünktliche Auszahlung des Lohns
- i.d.R. unbefristete Arbeitsverträge
- Bis zu 30 Tage Urlaub
- Urlaubs
- und Weihnachtsgeld
- Individuelle Schulungen/Qualifikation/Weiterbildungen
- Kostenübernahme bei arbeitsmedizinischen Vorsorgeuntersuchungen
**Kontaktdaten für Stellenanzeige**
apero GmbH
Frau Poser
Personaldisponentin
Marktplatz 1
88400 Biberach an der Riß
Deutschland
Telefonnummer: +49 (73 51) 82 98 63 20
Faxnummer: +49 (73 51) 82 98 63 36
Art(en) des Personalbedarfs: Neubesetzung
Tarifvertrag: iGZ-DGB (100% nach IG Chemie)
Entgeltgruppe: E 09T