Freelancer profile translated to English.
Back to original languageAbout Roman
Since 2016, project experience in the GMP-regulated environment.
Through my regulatory understanding, hands-on mentality, and a structured, quality-oriented approach, I have frequently been entrusted with diverse projects, complex issues, and challenging situations.
This versatile experience and my quick comprehension enable me to effectively support projects from the outset.
German
Native or bilingual
English
Conversational
Can work on-site
Stuttgart (up to 50km)
Experience
- Ingenieurbüro LemkeFreelancerPHARMACEUTICALS INDUSTRYJanuary 2020 - Today (6 years and 5 months)Freelancer/Project Engineer in the GMP-regulated environmentAreas of activity:- GMP-compliant qualification of plants, equipment, storage- Computer System Validation (CSV) including backup/restore, ERP, QC systems- Processing of deviations, root cause analyses, CAPAs, risk analyses (including FMEA)- Creation and optimization of SOPs & concepts / GMP and pharmaceutical consulting- Interface coordination (QA, production, engineering, IT, external partners)- Technical leadership of small teams and new colleaguesCompetencies:- Structured and independent way of working- Planning, coordination of interdisciplinary tasks, and guidance of teams and service providers- Moderation of technical discussions- Solution-oriented with a focus on causes and project success- Quick comprehension of new topics and complex contexts- Sound knowledge in GMP (EU & FDA), GDP, GAMP 5, etc.
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