SQAFYI - Software QA Resource - FYI

US: Software Quality Engineer

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.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI

US: Software Quality Engineer