Extract from previous activities
2022 – datePharmaceutical Company, Germany (via K-Recruiting)
GMP-Consultant – Start Up Fill & Finish
Determination of the required documents for the new production area & gap analysis
Preparation and execution of PQs (in particular vial cleaning systems, depyrogenation tunnel, filling system, loading and unloading system freeze dryer, flanging machine, external cleaning machine, stopper treatment system, automatic cleaning machine, autoclave, inspection machines, utilities)
Preparation of risk analyses
Preparation of validation documents (including cleaning validation, sterilization of equipment, semi-automatic inspection)
Project management for the start-up phase (incl. creation of GMP-relevant documents)
Creation of processes and illustrations in SOPs
Execution of trainings of the SOPs
2021 – 2022Biotechnological Company, Germany
Expert Qualification & Validation for new production plant
Verification of FAT/SAT and documentation
Perform risk analysis, qualification plans, IQ/OQ/PQ test plans, protocols and reports incl. CSV & automation for:
Cell cultivation and bioreactors
Ultra- and depth filtration
Tangential flow filtration
Multiple chromatography systems
Filter integrity testers
Small and laboratory equipment
cleanrooms, airlocks with control and ventilation systems
Cleanroom monitoring (temperature, humidity, MiBi, particles)
WFI generation, storage and distribution, monitoring of WFI systems (MiBi, trending, process capability, etc.)
Utilities
Single-Use
2020Pharmaceutical Company, Germany (via K-Recruiting)
Expert Process Validation
2020Biotechnological Company, Germany
Consultant – Plant Start Up
Preparation and performace of qualification plans and reports for: Glove Integrity Test System (software, database and equipment), Glove Life Cycle System Software, IPC Equipment, LAF Units, Small devices, Single-Use
2020Biotechnological Company, Germany
Expert Root-Cause-Analysis, USP
Conduct/lead a structured root cause analysis on observed analytical out of trend results in the context of tech transfer of a complex biotech product
In-depth analysis of available data, definition of a problem statement, formulation of hypotheses, proposal of experiments to confirm or falsify the hypotheses and finally to define the root cause and corresponding corrective actions and preventive actions
Assessment of the deviation from the point of view of risk management and submission to authorities
Preparation of a report on the Root Cause Analysis
2019 – 2020Biotechnological Company, Germany
Project Management Bio-Engineering, Technology & Automation (Fermentation & Upstream Processing)
Review and preparation of automation planning documents
Project management for the new installation of a CIP system
Review of CSV/IT maintenance plans/reports, migration documentation and data archiving
Creation of topology and EMSR plans for automation
Creation, review and commenting of CSV and DI SOPs, P&IDs and design docs
Spare part management of automation hardware and components
2019Pharmaceutical Company, Germany
Qualification-Expert (New production plant)