Roman I.
Lab Team Leader
Experience
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.
CTA
Pharmaceutical manufacturer
- In the quality control department of a pharmaceutical manufacturer.
Project Manager & Consultant
Qualitätswandel
- In the field of pharmacies, medical devices, and the pharmaceutical industry.
Summary
Goal-oriented project manager with solid multi-year ISO and GxP experience in pharmacies, medical device manufacturers, and the pharmaceutical industry
Communicative | Leadership skills | Responsible | quick learner & problem-solving skills | analytical skills | flexible and innovative
Project management and interim management including personnel management in quality assurance and laboratory leadership
Advising 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 leadership
Personnel management
Consulting
Process optimization
Lean management
Supplier management
Languages
Education
Master · Chemistry
University of Applied Sciences entrance qualification
Certifications & licenses
Instructor qualification exam
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