Roman Ickert
CTA
Experience
CTA
- 7 years of experience as a CTA in quality control at a pharmaceutical manufacturer
Project Manager & Consultant
- 2 years of experience as a project manager & consultant in pharmacies, medical devices and the pharmaceutical industry
- risk assessment according to ISO 14971 and ICH Q9
- method and process validation
- validation of computerized systems
- organizing stability studies
- planning and conducting supplier audits
- support during inspections by authorities and notified bodies
Lab Team Leader
- 5 years of experience as a lab team leader in the field of in vitro diagnostics
- leading a team focused on product validation and stability studies
- responsible for project, personnel and resource planning
Summary
Goal-oriented project manager with solid, multi-year ISO and GxP experience in the areas: pharmacies, medical device manufacturers and pharmaceutical industry
Skills
Communicative
Leadership Skills
Responsible
Quick Learner & Problem-solving Skills
Analytical Ability
Flexible And Innovative
Project Management And Interim Management Including Team Leadership In Quality Assurance And Lab Management
Consulting And Supporting Stakeholders
Establishing And Maintaining A Quality Management System
Creating Iso And Gmp Compliant Documents
Planning, Qualifying And Maintaining Cleanrooms
Risk Assessment According To Iso 14971 And Ich Q9
Method And Process Validation
Validation Of Computerized Systems
Organizing Stability Studies
Planning And Conducting Supplier Audits
Support During Inspections By Authorities And Notified Bodies
Project Management
Team Leadership
Consulting
Process Optimization
Lean Management
Supplier Management
Ms Office
Mac Os
Adobe Sign
Sharepoint
Trackwise
Waters Empower
Sciex Analyst
Languages
Education
Master · Chemistry
Certifications & licenses
Trainer aptitude test
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