Manager QA & Projects

• Jul 2022 - Present

Manager Quality Management & GxP compliance

• Jan 2022 - Jul 2022

Manager System Validation

• Mar 2021 - Jul 2022

Junior Validation Manager (Computerized Systems)

• Apr 2018 - Mar 2021

- Ensuring compliance with validation relevant regulatory and internal requirements during entire system life cycle (e.g. 21 CFR Part 11, EU GMP Annex 11, PIC/S PI 001-3)- Computerized System validation support during GxP system lifecycle, including >Validation Strategy definition >Preparation of Validation Plan/Report >Review of validation relevant documents (RA, Test cases, Data Integrety Assessment, etc.) >Monitoring and follow up of validation deliverables >Coordination of peirodic review of CS >Change management for CS- Support in the coordination, creation and maintenance of global QM documents in relation to computerized systems. - Project management support Show less

bGlobal Quality Trainee

• Sep 2017 - Feb 2018

- Gap assessment for USP 1790 Visual inspection for injections. - Participation of QC Lean Lab Assessment in two different plants of Fresenius Kabi (Graz, Halden) and consolidation of quick-wins from different resources. - Events ( Deviations & Incidents) trending analysis based on root causes and affected area, to identify negative trend and seek for improvement. - Conduct " Cost of Poor Quality" calculation. - Gap assessment for USP 1790 Visual inspection for injections. - Participation of QC Lean Lab Assessment in two different plants of Fresenius Kabi (Graz, Halden) and consolidation of quick-wins from different resources. - Events ( Deviations & Incidents) trending analysis based on root causes and affected area, to identify negative trend and seek for improvement. - Conduct " Cost of Poor Quality" calculation.

bGlobal Quality Trainee

• Mar 2017 - Aug 2017

- Harmonization of deviation classification from different systems. - Evaluation of IPC (In-Process-Control) process in the filling line and packaging stages. - Identifying the most frequent root causes based on deviation trending analysis, defined effective CAPAs. - Compilation of GMP gap assessment for excipient. - URS (User Requirement Specification) compilation for a training tracking and management tool. - QC lean lab assessment for process optimization to improve the lead time of the analysis results. Show less

bGlobal Quality Trainee

• Sep 2016 - Feb 2017

- KPI (Key Performance Indicator) evaluation: Review quality KPI trends on plant and GO (Gloabal Operation) level, support quality metrics meetings held in plant Bad Homburg and Beijing via telecon. - PQR (Product Quality Review) compilation: Accomplished PQR of 4 Fresubin tube feed product for the Chinese market in 2014 and 2015. - Set up microbiological method validation plan for QC. - Evaluation the change of Vitamin C level in different product at different in-process-control steps. Show less

Research Intern

• Mar 2015 - Aug 2015

• TIFN Project: Spores and Predictive modelling for Geobacillus stearothermophilus • Bacterial spore production and microscopic examination of their physiological stages. • Performed heat inactivation experiments for spores of 18 G. stearothermophilus strains within 4 months • Data analysis with Excel Solver add-in and performed modelling on the data-sets obtained. • Characterized heat resistance of spores of these 18 strains. • Determined variability factors of 18 strains in terms of heat resistance. • Co-author of the paper regarding spore heat resistance. • Received a performance mark 8 out of 10. Show less

Research Intern

• Sep 2014 - Mar 2015

Conducted MSc thesis: Emerging food safety risks with relation to unauthorised GMOs - Identification and detection. • Literature review on the GMO detection methods and regulations from different countries. • Evaluated 10 filters of GMO under the EFSA tab menu on MediSys in order to optimize the detection of emerging food safety risks such as unauthorised GMO. • Detection of GMO in real-life samples: feed/food matrix. • Performed confirmation analysis of all the GMO elements and structures in reference material. Show less

Senior manager of animal laboratory and facility

• 2007 - 2013

• Supervised animal care staff in the day-to day operations and activities of the vivarium facility to support research activities as well as to ensure compliance with SOPs (Standard Operating Procedure) and protocol requirements. • Drafted and updated SOPs, documentation skills. • Laboratory animal quality control: quarantine and provided veterinary care; communicate with animal suppliers concerning animal quality or welfare. • Completed annual inspection and reports required by government, as well as GLP laboratory accreditation inspection from China Food and Drug Administration (CFDA) in coordination with senior management team. • As a member of Laboratory Animal Welfare Committee ensured high level of animal welfare and ethic throughout the entire research period. • Participated as a technician in different toxicological study projects. • Developed training sessions for new staff members. Show less