QM Pharmaceutical & QM/RA Medical Device

I provide my clients from the medical device industry with support in
the areas of interim management of QM processes, Change
control, Deviation management, CAPA management, Audit
management (Lead Auditor) for internal-, external- and supplier
audits and Supplier management. All processes have been my
daily hands-on tasks for the last 6 years in different companies.
I am also pleased to support you in the areas of technical
documentation, project management and PRRC.
In the pharmaceutical industry, I can also support the area of Batch
Record Review and QM processes with 6 years of on hand
experience.
I am familiar with MDR 2017/745, ISO 13485, US FDA 21 CFR
820 ff, MDD 93/94/EEC, EU GMP Guideline / ICH Q10

• Quality Management in Medical Device (highest Class III and CMD) and Pharmaceutical
• Regulatory Support in Medical Affairs
• Project Management
• Audits (internal, Notified body and Supplier)
• Suppliermanagement
• KPI and Management Review
• PRRC
• Suppporting Technical file
• CAPA Management
• Change Control
• Deviation Management
• Compliant Management
• Trainings Management
• Standard / Regulation Management
• Batch Record Review (Pharmaceutical)