Alsbach-Hähnlein, Hesse, Germany
EXPERIENCE PROFILE • batch record review/ batch approval, GxP-documentation and Downstream Process • Background in pharmaceutical industry • Sound knowledge of GMP guidelines and pharm. Eur. methods • QM documentation according to GDocP (SOP, validation reports, protocol) • Qualitiy Control and Quality Assurance • Drug Product Development • Analytical Method Validation • Software (SAP, LIMS, SoftmaxPro, PLA) • High quality orientation and strong can-do approach • ASR and PQR writing • Deviationmanagement, CAPA
Main tasks: PQR writing & CAPAs Deviationmanagment
Qualification/Validation: •Preparation and implementation of standard-equipment qualification •Preparation of qualification reports •Continuous exchange with our customer •check of GMP-Documents •Assistance in GAP-Assessment •Assistance in Cleaning-Validation •Assistance in Cleaning-Design QA: • Checking batch documentation for data integrity (according to ALCOA+) in downstream process (DSP) • Creation of controlled checklists • Direct support for production employees, team leaders, QA or production managers in the processing of corrections • Completion and approval of processed checklists • writing Product Reports (APQRs, ASRs) • projectmanager for stability project • create TPM data and incorporate into PQRs
Potency-Assay Entwicklung/Validierung unter GxP, GxP-Probenmessungen, Datenanalyse und Datenbankmanagement, Erstellung /Aktualisierung von SOPs und Laborberichte, SME für Geräte, Zellbankoptimierung
GMP: -Arzneibuchtests -Bioassay -Geräteverantwortung -SOPs anpassen
Abteilung „pädiatrische Neuroonkologie“ -Zellkultur (Adhärente- und Suspendionszellen) -Cytostatika-Arbeiten -mol.biologische und mikrobiologische Arbeiten