Keywords
SAP
GCP
R&D
Software validation
SDLC
ISO 9001
Pre-sales
CISA
clinical trial
Computer Systems Validation processes
Life Sciences
GAMP 5
21 CFRPart 820
ITIL V3
Quality Center
Sales
Configuration Management
Audit
Quality Assurance
Quality Management
Project Management
Quality Manager
Reporting
Change Management
Service Management
Pharma
Program Manager
Good Clinical Practice
Skills
Background in IT and Quality Management, experienced in Computer System Validation (SAP, EDC systems)
Service Management
Worked in Pharmaceutical/Vaccines and Clinical (CRO) industry
Worked as T&M consultant and on fixed price projects
Performed pre-sales, operational, oversight and reporting activities
Service Management
Worked in Pharmaceutical/Vaccines and Clinical (CRO) industry
Worked as T&M consultant and on fixed price projects
Performed pre-sales, operational, oversight and reporting activities
Project history
Currently working as Quality and Training manager within the Business & Decision Life Sciences CRO
Contibuted and managed external projects related to audit or Computer System Validation
Responsible for maintaining QMS, Quality Oversight, IS Compliance, Training requirements
Previous job as T&M consulant at GSK, SAP Validation (security)
Review of role specification and related test protocols before and after execution
Contibuted and managed external projects related to audit or Computer System Validation
Responsible for maintaining QMS, Quality Oversight, IS Compliance, Training requirements
Previous job as T&M consulant at GSK, SAP Validation (security)
Review of role specification and related test protocols before and after execution
Local Availability
Only available for the countries
Belgium
For (nearly) full time assignement East or center of Belgium or wider if work can be done partially remotely
For short assignements (few days, e.g. trainings, audit) internationally available.
6 weeks notice period
For short assignements (few days, e.g. trainings, audit) internationally available.
6 weeks notice period
