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Drug Product Quality Specialist
vor 3 Monaten
Standort: Biberach
Anstellungsart(en): Vollzeit
Arbeitszeit: 37,5 Stunden pro Woche
Zweck und Ziel der Stelle
Die apero GmbH steht als gesellschaftergeführtes Unternehmen für Kompetenz und Zuverlässigkeit im Bereich der Arbeitnehmerüberlassung und Personalvermittlung.
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, eine*n Drug Product Quality Specialist (m/w/d).
Aufgaben, Kompetenzen und Verantwortung
- Betreuung und Bearbeitung von Diskrepanzen (Events und Abweichungen) als QA-Verantwortlicher innerhalb der BioPharma Drug Product Einheit und Quality Control
- Betreuung und Bearbeitung von OOX als QA-Verantwortlicher
- Durchführung von Prozessbeobachtungen in den Produktionseinheiten der BioPharma Drug Product der Sterilabfüllungen (Isolatoren und RABS-Linien), Visuelle Inspektion und Verpackung
- Überprüfung und Genehmigung von Änderungsanträgen und Dokumenten innerhalb der BioPharma Drug Product Einheit und Quality Control. Vertretung der QA in Audits und Inspektionen
- Sicherstellung der Regulatory Compliance sowie Einhaltung der internationalen cGMP und internen Vorschriften
- Unterstützung bei der Verbesserung des internen Qualitätsmanagementsystems und bei der Definition einheitlicher Standards
- Ansprechpartner für sämtliche Fragen zum Thema Quality in Bezug auf die Produktions- und QC-Prozesse im laufenden Betrieb
- Nachverfolgung von qualitätsrelevanten Aufgaben und Entscheidungen sowie selbständige Entscheidungsfindung bei Routineaufgaben. Proaktives Handeln und Eskalation, wenn notwendig
- Versetzte Arbeitszeit und Bereitschaftsdienst, gegebenenfalls Wochenendarbeit je nach Produktionsanforderung
Es handelt sich bei dieser Position um ein hybrides Arbeitsmodell, welches an 1 Tag pro Woche bzw. nach Bedarf aus dem Home-Office/Remote abgedeckt werden kann. Die Einarbeitung findet vor Ort statt.
Fachliche Anforderungen
- Master-Abschluss mit mehrjähriger Berufserfahrung oder vergleichbare berufliche Qualifikation in den Bereichen Pharmazie, Biopharmazie, Biologie oder Chemie
- Erweiterte Kenntnisse zur biopharmazeutischen Herstellung (Sterilabfüllung, Visuellen Kontrolle und Verpackung), besonders in Bezug auf compliance-/qualitätsrelevante Themen bei der Prozess- und Qualitätskontrolle mit langjähriger Berufserfahrung in Bezug auf GMP Compliance- und Qualitätsthemen
- Gute Kenntnisse der regulatorischen Anforderungen
- Erfahrungen in Audits und Inspektionen
- Gute Verhandlungs- und Kommunikationsfähigkeit ist erforderlich, um interne Vereinbarungen zu erreichen sowie gute Teamfähigkeit
- Gute Englischkenntnisse in Schrift und Sprache
- Flexibilität in der Arbeitsplanung: Versetzte Arbeitszeit und Bereitschaftsdienst, gegebenenfalls Wochenendarbeit je nach Produktionsanforderung
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
Art(en) des Personalbedarfs: Neubesetzung
Tarifvertrag: GVP-DGB (100% nach IG Chemie)
Entgeltgruppe: E12T
