Extensive experience in the validation process of most common Computerised Systems used in the Life Science environment (e.g. MES, LIMS, Lab Systems, DCS, QMS, PCS) according to GAMP5 guideline and Data Integrity Assessments execution aiming to identify in a detailed way relevant gaps and non-conformities. She is currently supporting a pool of pharmaceutical companies in the establishment of compliant solutions for their facilities and departments, Data Integrity Governance and in the resulting Data Integrity Assessment and Remediations.
Nicole Hoeger, Regional Operations Manager DACH Area, PQE GmbH
Graduated in industrial biotechnology, professional engineer with advanced knowledge in GxP, business processes, ERP systems and complex laboratory systems. computerized system validation, Data Integrity and project management. Knowledge of Agile methodology as well as traditional project and team management strategies. Experience in pharmaceutical/ biopharmaceutical industry combined with increasing responsibility roles in international pharmaceutical companies.