Senior Software Tester
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As a Senior Software Tester working in the Medical Device industry you will:
* 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.
* Senior software tester will 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.
* 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.
* Software Tester with a Proven track record in development / execution of Validation programs in areas of Systems
* Run / Manage complaint investigation and resolution of same.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales