SOFTWARE TESTER required for our medical device client in Limerick (initial 6 month contract).
The Software Tester will be involved with the identification and root cause analysis of potential bugs. You will also participate in troubleshooting and managing defects through a defect tracking system.
Role of this position
- Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
- Work with the various departments / groups in development and execution of validation activities associated with new system or System upgrades.
- Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
- Prioritize qualification activities in line with the project schedules and business needs.
- Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.
- Execute qualification protocols as required including risk assessments and regulatory reviews.
- Resolve and assist in the closure of deviations initiated during qualification execution.
- Complete 21 CFR Part 11 and Annex 11 Assessments Implementation and co-ordination of the change control process, review change controls for validation impact, promotes timely approval of all supporting documentation.
- Validation representative at daily project management meetings, weekly change control and team meetings.
- Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process / product introductions.
- Third level Degree in a Computer Science or a related discipline.
- 3+ years' experience of testing GxP Software applications and working in a highly regulated environment (ideally medical devices).
- Proven track record in development / execution of Validation programs in areas of Systems Run / Manage complaint investigation and resolution of same desirable.
Please call Michelle Galvin today for further information on 091 373 938 or email: email@example.com
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