GMP Qualification Expert - Lab Production & Systems
K-Recruiting GmbH
GMP QUALIFICATION EXPERT – LABORPRODUKTION(M/W/D)
Aufgaben Erstellung und Review von DQ-, IQ-, OQ-, ggf. PQ-Dokumenten Entwicklung von risikobasierten Qualifizierungsstrategien Koordination von FAT/SAT im Labor- und Automatisierungsumfeld Qualifizierung von: Chromatographie-Systemen mikrobiologischen Prozessanlagen Reinrauminfrastruktur HVAC und Medienversorgung Schnittstellen zur Automatisierung Validierung GMP-relevanter Computersysteme gemäß Annex 11 Umsetzung von 21 CFR Part 11 Anforderungen (Data Integrity) Erstellung von: URS / FRS / DS ;Reviews Risk Assessments; Traceability Matrices; Testprotokollen Validierung von: Laborautomatisierungssystemen SCADA / Prozessleitsystemen LIMS-Integration elektronischen Chargendokumentationen Sicherstellung der ALCOA+ Data Integrity Prinzipien Qualifikation Mehrjährige Erfahrung in GMP-Qualifizierung von Produktionsanlagen Sehr gute Kenntnisse in Computer System Validation (CSV) Fundierte Kenntnisse in: EU GMP Annex 11 21 CFR Part 11 GAMP 5 (risikobasierter Ansatz) Erfahrung in automatisierten Produktions- oder Laborumgebungen Idealerweise Erfahrung im Biotech- oder Insulinumfeld Sicherer Umgang mit Contamination Control Konzepten Rahmendaten Start : flexibler Start, Asap oder Mitte 2026 möglich Dauer : 6 Monate Auslastung : 5 Tage die Woche Einsatzort : Großraum Frankfurt #J-18808-Ljbffr K-Recruiting GmbHVacancy posted 1 day ago
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