Beschreibung

Subject Matter Expert (SME) specialized in validation of GxP processes with experience in process validation, risk assessment, Lean Six Sigma, and GMP documentation. I partner with organizations in strengthening compliance frameworks and optimizing GxP processes, including automation and digitalization. Let me know how I can support GxP, validation, regulatory compliance, and digital improvement initiatives in your organization.

Branchenexpertise

Sprachen

Englisch
Muttersprachlich oder zweisprachig
Niederländisch
Muttersprachlich oder zweisprachig
Deutsch
Konversationssicher
Französisch
Grundkenntnisse

Arbeitsortpräferenzen

Vor Ort möglich

Frankfurt am Main (bis zu 50 km)

Stavigent
VALIDATION CONSULTANT
Dezember 2025 - Heute (6 Monate)
Independent consultant for GxP processes in the life sciences industry:
- Delivered project-based freelance work in a GxP environment, operating independently across multiple client requirements
- Strengthened expertise in Lean Six Sigma, building on prior industry experience.
- Updated knowledge of GAMP, with a focus on equipment validation and compliance requirements in regulated environments.
- Currently undertaking training in AI applications in GCP, focusing on the use of AI in clinical trial processes and compliance frameworks.

Selected projects:
- AI Validation in GCP Research: Supported validation considerations for AI in GCP research and clarified customer regulatory expectations.
- Validation Data Analysis & Trend Reporting: Consolidated validation data into one dataset and visualised trend analysis, supporting process improvements, clearer reports, and better regulatory compliance.
- CAPA & Deviation Monitoring (Visual Analytics): Developed interactive dashboards consolidating CAPA and deviation data, using trend visualisation, improved tracking of key quality metrics, and strengthened audit readiness and regulatory compliance.
GMP Validation Project Management Quality Assurance Regulatory Compliance Lean six sigma
BioSpring GmbH
VALIDATION MANAGER
November 2023 - Oktober 2025 (1 Jahr und 11 Monate)
Frankfurt, Germany
Validation and manufacturing regulatory support of (c)GMP oligonucleotide manufacturing processes for commercial programs, clinical phases I-III, and diagnostics in the area of cell and gene therapies:
- Writing IND/CTA documents for customers (life sciences industry)
- Writing internal GMP documents
- Drafting risk assessments for internal processes and for customers
- Preparing and presenting validation data for external audits
- Collaborating with QA, QC, R&D, Regulatory Affairs, and Manufacturing
- Working experience with ISO (9001, 13485) and international guidelines (ICH, FDA, EMA, PMDA)
GMP Validation Regulatory Compliance Quality Assurance Lean six sigma Project Management
Biomolecular Magnetic Resonance Centre
RESEARCH SCIENTIST
November 2017 - Oktober 2023 (5 Jahre und 11 Monate)
Frankfurt, Germany
Conducted in-depth research on ABC-transporters, focusing on therapeutic areas such as antibiotic resistance and oncology, utilizing solid-state NMR techniques:
- Probed the effect of inhibitors and substrates
- Developed kinetic assays for liquid-state and solid-state NMR
- Optimised membrane protein production workflow (in lipids and detergents)
Data analysis Experimental Design Critical Thinking Project Management Statistical Analysis