Pharmacist & Quality and Compliance Manager

4/2019 – 8/2019

- Realization and Implementation of Validation
strategy for local and global
Document IT Management Systems and
Laboratory Computer Systems
Providing strategy and advice to establish a Corporate Framework for
Project Governance of Computer System Validation and Equipment
Qualification during Laboratory Relocation (incl:GAMP5).
- GxP Compliance Analysis and Risk Assessment (FDA,WHO, ICH)
- Creation and Coordination Testing (IQ, OQ, PQ)
- Development and creation of a Traceability Matrix
- Data Integrity (ALCOA, GAMP5, FDA, GMP)

Pharmazie, Prozessvalidierung

2/2019 – 8/2019

- Laboratory Re-Localization
- Creation and Realization Critical Assessment for
Laboratory Equipment (GxP- Criticality Assessment)
- Analysis of the Laboratory Equipment
- Qualification of Laboratory Equipment (FDA, WHO; GMP)
- Requirements Engineering for a new
Work and Department Environment (GxP)
- Data Flow Process Analysis
- Visualization and perform a Data Flow Process Map
for all Business Process and Laboratory Infrastructure (VISO, Miro)
- Laboratory Process Gap Analysis
- Data Integrity for Laboratory (ALCOA, GAMP5, FDA, GMP)

Pharmazie, Medizintechnik

1/2019 – 4/2019

Test

European foundation for quality management (EFQM)