Opex PE Manufacturing Cycle Time reduction

SME Investigations & Stability- Continuous improvement - Process mapping (as is and to be)- Stakeholdermanagement- Translate processes into requirements and procedures

QA officer- Set up Quality agreements- Set up EU BPR submission files for medical devices- Set up and review Change requests- Support investigations of non-conformities - Product quality review

QA officer - Investigation of quality incidents, deviations/OOS - Evaluation and follow-up of change controls. - Participating within continuous improvement projects on QA processes. - Review of documents, in accordance with cGMP/ GDP guidelines.

Master data builder gLIMS (Labware)- Collect and set up master data.- Program master data in Labware- Perform Performance validation on master data set-up- Responsible person for writing, follow-up and trending of deviations, CAPA and change requests (Trackwise QTS)- Ensuring that the documentation is in accordance with cGMP/ GDP guidelines.

QC analyst- Execution of QC-analysis (Small tests, HPLC, UV spectrophotometry), - Responsible person for writing, follow-up and trending of deviations, CAPA and change requests (Trackwise QTS/excel)- Point of contact for quality issues in the chemical laboratory. - Ensuring that the documentation is in accordance with cGMP/ GDP guidelines.- Participatin in continuous improvement project on data review

Research on asthma and COPD at the Department of Respiratory Medicine on mouse modelsPerforming RNA/DNA-extraction, PCR and qPCR/ RT-PCR, genotypingElisa and Western BlotLung digestion, cell surface staining and intracellular stainingImmunohistochemical staining on paraffin-embedded lungsectionsStaining of tissue and cells (H&E, May-Grünwald Giëmsa, Congo, Sirius red, PAS,...)

Quality checks on raw materials, intermediates and finished soy products such as determination of protein, calcium content, dry matter, residual oxygen, density, viscosity, sensory analyzes.Processing of results (Excel & SAP).Calibration of the necessary equipment.

Stability studies for drug development in a GMP/GLP environment.Performing HPLC and UPLC analysis, gas chromatography, dissolution tests.Processing and reporting of results (LIMS, Waters Empower, ...)Quality control of results

Characterization of human embryonic stem cells by immunofluorescence staining and RT-PCR