Vincent T.

Involvement in IT projects as an IS QA representative (for new implementations/version upgrades/impact analysis):

Provided recommendations, approval, review of project deliverables:

Qualification protocols, supplier evaluations, system risk assessments etc.

Raised awareness among teams about adherence to quality SOPs. Standardized project deliverables in terms of quality ensuring compliance with current regulations

Quality SOP: Management of Non-conformities. Periodic review of GxP systems

CSV SOP (monitoring period, change management, releases); validation templates

General administration SOP for systems

VMP (Validation Master Plan) and annual report

Monitored quality deviations/CAPA/system-related changes and infrastructures

System operational deviations register, change controls board

Carried out the periodic review of critical computerized systems

Starlims (LIMS), Copilote (shipment), Antares (equipment serialisation), Carl (maintenance)

Drew up the validation strategy for the new Ennov system (eDMS part & RIM part) : criticality & validation plan

Updated relevant IS procedures to align with the current needs & applicable regulations

Become an auto-entrepreneur to work directly with other companies. Expertise: Systems Validation, Quality System Management, software qualification/ tester, Desired sector: Pharmaceutical, Medical devices, Biotech, food-processing industry.