Description
Senior Software Tester/Limerick, Ireland/12 Months Contract/Up To 35 EUR Per Hr
The Role
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.
The Company
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.