US: Software Quality Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
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
Team SQAFYI - Software QA Resource FYI