Roman Ickert
Laboratory Team Leader
Experience
Laboratory Team Leader
- In the field of in vitro diagnostics.
- Leading a team with focus on product validation and stability studies.
- Responsible for project, personnel, and resource planning.
CTA
Pharmaceutical Manufacturer
- In the quality control department of a pharmaceutical manufacturer.
Project Manager & Consultant
Quality Change
- In the fields of pharmacies, medical devices and the pharmaceutical industry.
Summary
Goal-oriented project manager with extensive, multi-year ISO and GxP experience in the fields of pharmacies, medical device manufacturers, and the pharmaceutical industry
communicative | leadership skills | responsible | quick comprehension & problem-solving skills | analytical ability | flexible and innovative
Project management and interim management including personnel management in quality assurance and laboratory management
Consultation and support of stakeholders
Establishment and maintenance of a quality management system
Preparation of ISO- and GMP-compliant documents
Planning, qualification, and maintenance of cleanrooms
Risk assessment according to ISO 14971 and ICH Q9
Method and process validation
Validation of computerized systems
Organization of stability studies
Planning and execution of supplier audits
Support during inspections by authorities and notified bodies
Project leadership
Personnel management
Consultation
Process optimization
Lean management
Supplier management
Languages
Education
Master · Chemistry
Advanced technical college entrance qualification
Certifications & licenses
Trainer Aptitude Examination
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