Philipp Seidl verfügbar

Philipp Seidl

CSV Consultant

verfügbar
Profilbild von Philipp Seidl CSV Consultant aus
  • Freelancer in
  • Abschluss: M.Sc./ Dipl. Ing. Bioprocess Eng.
  • Stunden-/Tagessatz:
  • Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | portugiesisch (verhandlungssicher) | spanisch (Grundkenntnisse)
  • Letztes Update: 12.01.2021
SCHLAGWORTE
SKILLS
Personal Profile
• Comprehensive hands-on experience of change management, new validation and post Go-Live support as project and sub-project management (requirement documentation, creation of business blueprint, integration management, SOP and quality management regulation documents, testing, data qualification, support)
• Consultant for GAMP 5 and CFR part 11 conform validation of computer systems
• 3-years of professional experience within ongoing validation of diagnostics RND software (GAMP Class 5), 1-year of experience in method validation in pharmaceutical quality control (ICH Q2(R1))
• 5-years of experience in chemical, pharmaceutical and diagnostical industries
• Expert within process management in quality management, with a specific focus on software application change management and infrastructure validation
Expertise
• Pharmaceutical, diagnostical and Biotechnology
• GLP/GxP-relevant processes
• Excellent communication skills
• Strong analytical and methodical skills
• Project Management of teams with up to 15 employees
• Experience in coordination of Near-/Offshore Teams
• Process and SAP Implementation within the area of SAP QM
• Customizing and validation of the Software development tools DevOps and TFS
• Ongoing computer system validation of GAMP class 5 and Infrastructure validation
PROJEKTHISTORIE
3 Jahre Projekterfahrung als Validation Lead bei Roche Diagnostics QM and QC System Consulting bei Scheer GmbH
ZEITLICHE UND RÄUMLICHE VERFÜGBARKEIT
Ich suche Remote-Projekte

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