Description
Senior Software Tester - Validation/CSV
Leading global pharmaceutical client require a Senior Software Tester within their Validation team based in Limerick.
Responsibilities:
* Identification and root cause analysis of potential bugs.
* Participate in Troubleshooting.
* Manage 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 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.
* 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.
* 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.
Experience:
* Proven track record in development/execution of Validation programs in areas of Systems
* Run/Manage complaint investigation and resolution of same.
Please apply now for more details!