Marlen Dalkowski

Projekte: Jan '19 - Dez '19 - Data Integrity Remediation Plan; Analytical Services Quality (QC), CSL Behring GmbH, Marburg - Quality Management | Data Integrity | CSV | Project Management - Laws and Guidelines: GAMP 5 | EudraLex Annex 11 | 21 CFR Part 11 / 210 / 211 | AMWHV | Q8 | Q9 | Q10 | EudraLex Chapter 4 Documentation - Verification activities: IQ | OQ | PQ | SAT

Projekte: Dez '13 - Jul '14 & Jul '15 - Dez '16 - GMP / CSV Consultant; Hoffmann La Roche AG, Basel, Switzerland - Maintenance of the CSV documentation - Execution of CSV activities - Preparation and execution of Risk Assessments (FMEA) - Vendor Evaluation - Managing and evaluating TrackWise data - Manage and track audit / inspection findings - Document Management responsible - Training Management responsible - 1st & 2nd level user support for condor-User

Projekte: - Jan '06 - Dez '08 & Jan '11 - Nov '13 - Novartis Vaccines & Diagnostics GmbH & Co. KG (Marburg) - Jan '09 - Dez '10 - Siegfried Ltd. (Zofingen, Schweiz) - Project Coordination MARS Project - Documentation - Maintain, coordinate, plan and create hold time studies for product-touching media in the Atlas Systems (DMS) and TrackWise (QMS) - Maintain qualification documentation - RA and IQ - As-built specifications - SOPs