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.
* 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: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.