More than 20 years’ experience in Technical Quality Assurance, GMP Compliance & Interim GMP Lead Auditing
One of the top consultants for biotechnological process validation
Strong hands-on mentality combined with longstanding experience in leading positions
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Certified GMP-Auditor TEQ - GZBB Lean Six Sigma Black Belt Process Engineering Dipl. Biomedical Engineering MSc
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Process Validation, Biotechnological Processes, Process development, Upstream & Downstream, Cleaning Validation, Mammalian cells, Biologics, Vaccines, GMP, SOPs, API, CAPA, FDA, (Bio)Pharma
Key-Facts
Extract from previous activities
Biotechnological Company, Switzerland
Senior QA Manager and Validation Consultant
Quality Assurance
Cell culture process development and validation
Development of SOPs / Review of qualification Documents
Risk Management and investigation in a complex environment
General GMP-compliance of manufacturing processes
CAPA & Deviation Management
Validation & (SwissMedic) inspection readiness
Supplier & equipment qualifications
Various medical applications ATMPs in Clinical Phase I/II: Individual Human Cell Therapies/Stem Cells, Human Tissue/Organ, Expansion/transplantation & Cardiovascular Matrices
Top 5 Biotechnological Company, Switzerland
Tech Transfer & DSP Development Expert
Scale-up
Validation Activities
Deviation Management
Downstream Process Development
Clinical Phase III – New Vaccine/Biologics cell culture manufacturing
Gap Assessment of new GMPIII facility & qualification
Process development and TechTransfer
Biotechnological & Medical Devices Company, Germany
Consultant Tech Transfer & Lead Auditor
Audit/Inspection Trainer for international BioPharma / Vaccine Companies
BSL2 technical compliance in process development & validation
CAPA compliance
Clinical Phase III
Change management
Combination product
DS/DP mammalian cell culture process of EBOLA viral vaccine
US-FDA Inspection Readiness & Mock inspections
Active Medical devices ISO13485
Biotechnological Company, Germany
Interim Consultant QA / Tech Transfer / CMO
Equipment Qualification, Q-Compliance
Process validation for global market launch
Leadership & Team coaching/support
PPQ-batches
Drug Development
Aseptic Manufacturing
Stability, Process design
Deviations, Change control
Risk assessments
Supplier qualification GMP-audits EMEA/USA/Australia (FDA, EMA compliance)
Biotechnological & Medical Devices Company, Germany
Consultant Tech Transfer & Lead Auditor
CAPA-Consultant "FDA-compliance and inspection Readiness" of Deviations / CAPA system including remediation of deficiencies Class III Medical devices ISO13485
Manufacturing, equipment qualification, clean rooms, cleaning validation, product development, complaints, change control etc.