Description
Senior Software Tester
Limerick, 8 month day rate contract
Responsibilities of the role:
- Identify and carry out root cause analysis of potential bugs.
- Troubleshooting and Defect Management
- Work with internal teams in the development and execution of validation activities associated with new systems or systems upgrades.
- Validation in compliance with US and EU regulations (CFR Part 22 and Annex 11)
- Complete 21 CFR Part 11 and Annex 11 Assessments
- Provide input into all project phases ie 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.
- Implementation and co-ordination of the change control process, review change controls for validation impact, promotes timely approval of all supporting documentation.
- Generate SOP's/other documentation as applicable.
- 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.
- Proven track record in development/execution of Validation programs in areas of Systems
- Run/Manage complaint investigation and resolution of same.
For more information on this position contact (see below) or call
If you are not interested but know somebody who would be interested in this opportunity, please pass my detail on to them. For every candidate that is referred to Morgan McKinley and then placed in a permanent or temporary role for 3 months or more, the referrer will receive a €250 one for all voucher - It is essential they mention when contacting me that you have referred them.