US: Software Quality Engineer
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http://sqa.fyicenter.com/jobs/99654399_Software_Quality_Engineer.html
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http://sqa.fyicenter.com
Date: 24-Feb-2015
Software Quality Engineer
* Co-ordination, implementation and active participation in the site validation programme for computer systems, automated product/process systems and lab systems.
* Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
* Develop validation documentation as required (e.g. specifications, plans, protocols, procedures etc.).
* Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
* Execute qualification protocols as required
* Prioritize qualification activities in line with the project schedules and business needs.
* Prepare reports of executed protocols
* Resolve and assist in the closure of deviations initiated during qualification execution
* Initiate and implement change control activities in accordance with site procedures.
Key Skills and Competencies required:
* Relevant 3rd Level Qualification in science or engineering
* A minimum of 4 years IT validation experience in an established QA function preferably in the healthcare industry
* Strong knowledge of CSV/GAMP, 21CFR Part 11,Project Life Cycle and cGMP Regulations,
* Strong statistical skills and process capability are required along with excellent interpersonal, communication, facilitation and team working skills. Adaptable and flexible.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
US: Software Quality Engineer