— Experience

Senior Consultant

Valiate / 2023 - now

Project: Multi-Vendor packaging lines, Novo Nordisk, 25A, HI

Tasks
- 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
 Tasks
 - 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

Chr. Hansen, 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
 

— Courses

• Computer system Validation, CVS, Sep 202
• ECA – Computer Validation: The GAMP 5 Approach, Apr 2018
• Validation and Operation of Computerized systems, Oct 2017, A. Hvidstrup
• GMP Requirements for Computerized systems, Nov 2016, Peter Nyborg
• GAMP 5 Introduction, Nov 2015 (Confirm)
• Batch review investigation Oct 2014, John Lee

Contact

E-mail: troelsgodballe@gmail.com
Phone: +45 53607798