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US: Software Quality Engineer

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teste...@yahoo.com

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Feb 24, 2015, 4:46:54 PM2/24/15
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US: Software Quality Engineer
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99654399_Software_Quality_Engineer.html
To see other opportunities, please visit 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
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