Description
Senior Software Tester - Validation/CSV
Leading global pharma client require a Senior Soft with knowledge of Valisation (ideally within pharmaceuticals) for a 6 month contract in Limerick.
*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.
*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!