Purpose of position
The ITQA Specialist is primarily responsible for compliance review of software products and systems that are either built in-house or planned to be purchased externally i.e. bespoke or off-the-shelf. The Specialist partners with internal stakeholders to plan, test, and implement all IT related changes to ensure that products are conform to the desired quality and regulatory standards e.g., GMP, GDP and GAMP5. The Specialist is accountable for a thorough impact assessment prior system implementation and ensures that systems are operational and client ready.
Review, analyze, and evaluate business systems and user requirements, document requirements, define scope and objectives to meet overall business strategies. May serve as the primary liaison between IT and other (business) areas for all IT related applications and developmental activities.
The IT QA Assurance person is based in Hungary, member of the Global IT team and reports directly to the Global IT Manager in Denmark.
Roles and responsibilities
- Support in IT Development Strategy
- Evaluate all initiatives against the GMP and GDP legislation
- For external IT systems review SLA’s to ensure business and GxP requirements
- Develops test plan and user acceptance test plan (manual and automated tests are in scope)
- Prioritizes test scenarios and executes according to plan
- Creates and maintains the IT quality assurance processes and Testing guidelines
- Identifies upfront possible risks, logs, and tracks defects
- Provides reporting on and escalates technical issues if needed
- Alignment between IT department and QA requirements
- Alignment between IT and Business needs
- Follows standards in accordance with company policy and regulation
- Contribute to prepare business continuity and disaster recovery plan and manage tests
- Create and maintain documentation for IT systems
- Create and maintain IT system training material
- Contribute in IT Audits and manage GAPs identified