Expert Consulting within GxP IT Validation
+12 Years of experience within
- IT/OT Validation
- Quality
- IT compliance
- Data Integrity
- MES/DCS Validation
- Batch Report Validation
- TIMS
- CQV/CSV
- Test and Validation Management
E-mail: troels@valiate.com Phone: +45 53607798
Experience
Principal Consultant
Valiate / 2023 - now
Project: Multi-Vendor packaging lines, Novo Nordisk, 25A, HI
- URS
- pFMEA
- Dataflow
- IT Risk Assessment
- Batch Flow Validation
- GMBR validation (PAS-X)
- Test plan authoring
- FAT/SAT/IV/OV Execution
Senior Consultant
Kuatro Group / 2022 - 2023
Project: Multi-Vendor packaging lines, Novo Nordisk, 25A, HI
- URS
- pFMEA
- Dataflow
- IT Risk Assessment
- Test plan authoring
- FAT/SAT/IV/OV Execution
IT QA Validation Manager
Lundbeck, FP, various IT projects / 2021 - 2022
- Validation Lead
- Test Lead
- Data Integrity
IT QA Specialist
Novonesis, FP, greenfield project / 2019 - 2021
- Validation Strategy
- SAP Integration Validation
- Batch Report Validation (SAP)
IT & Validation QA
Novo Nordisk, API greenfield project / 2015 - 2019
- Validation Strategy
- DCS Validation (DeltaV)
- Batch Report Validation (Syncade)
- HP ALM Quality Center (TIMS)
QP Delegate
Novo Nordisk, FP, / 2013 - 2015
- Batch Release
- CAPA
Education
Cand. Scient (Biomedicine)
- Roskilde University, 2007 - 2013