Florian Kolb

Deviation mangagement for aseptic filling / lyophilisation / visual inspection

Method Remediation Ch.P.

Consultant for Pharmaceutical Industries (Life Science & HumanHealthcare) Process specialist - for aseptic filling, lyophilisation, formulation, QC Deviation management, Process improvement, CAPA Management, Risk Assessment

Process specialist - for aseptic filling, lyophilisation, QWC Certified owner investigator minor / major deviations Risk assessment - environmental monitoring CAPA management

Process specialist - for aseptic filling, lyophilisation, formulation, QC Certified owner investigator minor / major deviations / events CAPA management

Elternzeit

Process specialist - for aseptic filling, lyophilisation Certified owner investigator minor / major deviations Risk assessment - environmental monitoring CAPA management

Process specialist - aseptic filling, lyophilisation Certified owner investigator minor / major deviations Risk assessment - environmental monitoring CAPA management

Qualitymanagement, Quality assurance, Technicial production documentation, Productdevelopment, Production and procurement, Supplier qualification, Supplier audits in asia

Issue of standard operating procedures, Projekt tasks, Batch Record Review, Management Review, PQR

Bachelor Thesis: "Risk assessment - aseptic production process of single-dose parenteral formulations"

Product Quality Review Batch record review Issue of SOP's Qualification of a new surface desinfectant Gowning qualification to enter GMP class B cleanroom areas

Praktikum in der Abteilung Qualitätsmanagement Produktion. Aufgaben waren u.a. die Teilnahme an Selbstinspektionen, sowie das Mitwirken am Eröffnen und Bearbeiten von Abweichungen.

Reinigung von Reinräumen der Klasse C / cleaning of clean-rooms that correspond to class C of the GMP classification Dokumentation / documentation according to FDA and cGMP guidelines

Cleansing and sterilization of primary packaging materials and liquid filling equipment Clear documentation of all working processes according to FDA and cGMP guidelines Realization of In-process controls Monitoring of production lines, machines, and equipment in quality terms during routine operation Realization of cleansing and disinfection operations in cleanroom classified areas Aseptic filling of final bulk products

Cleansing and sterilization of primary packaging materials and liquid filling equipment Documentation of all working processes according to FDA and cGMP guidelines Realization of In-process controls Monitoring of production lines, machines, and equipment in quality terms during routine operation Realization of cleansing and desinfection operations in cleanroom classified areas Final Bulk production of "WFI" and solvents like NaCl-,CaCl- and Aprotinin solutions Final Bulk production of Refludan® LIMS

Life sciences, biotechnology (upstream / downstream), biochemistry, bioanalysis, specific fields of biotechnology law, cell culture technology, good manufacturing practice

Cleansing and sterilization of primary packaging materials and liquid filling equipment, Documentation according to FDA and cGMP guidelines, Realization of cleansing and desinfection operations, Monitoring of production lines, Aseptic production of liquide drugs, SAP,