Pharmaceutical Operations Manager
Vor 2 Tagen
MSAT ist Ihre Spielwiese? Sie haben Erfahrung in allen Bereichen der Produktion pharmazeutischer Produkte (Upstream, Downstream, DxP, Quality Control…) und sind bereit, diese ganzheitlich zu managen? Dann melden Sie sich
Unser Kunde sucht eine/n erfahrene/n Experten/in für die technische und analytische Betreuung pharmazeutischer Herstellungsprozesse.
Ihre Aufgaben:- Technische Leitung und Betreuung der Produktion pharmazeutischer Produkte, einschließlich Technologie-Transfer, Herstellungsprozesse und Qualitätskontrolle.
- Verfassen, Prüfen und Freigeben von GxP- und Qualitätsdokumenten zur Einhaltung regulatorischer Vorgaben.
- Management von Change Controls im MSAT-Bereich.
- Schnittstelle für Qualitätssicherung, Regulatory Affairs und externe Partner (CMOs, Labore, API-Lieferanten).
- Fachliche Beratung zu analytischen Methoden (HPLC, Endotoxine, Sterilität etc.).
- Unterstützung bei regulatorischen Anfragen und GMP-Compliance.
- Begleitung von Stabilitätsstudien und Verwaltung von Referenzstandards.
- Master-Abschluss in Life Sciences (Pharmazie, Chemie, Biotechnologie o. Ä.).
- Mindestens 5 Jahre Erfahrung in GMP-Umgebungen mit Fokus auf Herstellung (z. B. orale Formen, Injektabilia) und analytische Verfahren.
- Fundierte Kenntnisse im Qualitätsmanagement (CCs, CAPAs, Abweichungen).
- Organisationsstärke, Eigeninitiative und interkulturelle Kompetenz.
- Sehr gute IT-Kenntnisse (MS Office, Projektmanagement-Tools).
- Fließendes Englisch erforderlich, Französisch von Vorteil.
Klingt spannend? Dann bewerben Sie sich jetzt
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