General-Focus: 

• QA
• production
• production facilities (RRKL A-C)
• MDR
• Pharma
• QM System: Changes, CAPAs, deviations, qualification, validation

Work experience:

05/2020 - 02/2021

Role: Consultant - Radiopharmacology

Customer: Ipsen 

Tasks:

• QA interim management for the quality-related processes of clinical phases

12/2018 - 05/2020

Role: Consultant - MDR

Customer: Johnson & Johnson 

Tasks:

• IT implementation of document transfers from QA including their release

10/2018 - 12/2018

Role: Consultant - MDR

Customer: Straumann GmbH

Tasks:

• Support QA-Management
• Cleaning Validation in MDR Class 1a product

04/2017 - 09/2018

Role: Consultant - Aseptic filling of vaccines

Customer: GSK

Tasks:

• Document management and processing of changes, CAPAs and deviations. Preparation and follow-up of FDA and RP inspections

04/2016 - 03/2017 

Role: Project Manager

Customer: QPP GmbH

Tasks:

• Qualification and validation of newly built aseptic production facilities including preparation of documentation for international inspections
• Takeda ? Aseptic production and lyophilization Qualification and validation of the equipment and the manufacturing and filling process

03/2014 - 09/2014

Role: Internship QA Management / QC- Labor

Customer: Sandoz ? Novartis AT

Tasks:

• Method development - extractable volumes in prefilled syringes

Know-How:

• GMP / ICH Q10
• QA-Systeme
• TrackWize
• MS Office 365
• ISO 13485 /MDR
• SAP
• APQR
• REXS-Risk analyse