Description
EXCELLENT OPPORTUNITY FORSOFTWARE QUALITY/VALIDATION ENGINEERKey Tasks
?Project 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).
•Co-ordination, implementation and active participation in the site validation programme for computer systems, automated product/process systems and lab systems.
•Execute qualification protocols as required
?Prioritize qualification activities in line with the project schedules and business needs.
?Prepare reports of executed protocols
?Resolveand assist in the closure of deviations initiated during qualification execution
?Initiate and implement change control activities in accordance with site procedures.
•Co-ordinate re-validation activities
•Conduct training in validation methodologies and related procedures as required.
•Present validation systems at internal and external audits
• Key Skills and Competencies required:
?Relevant 3rdLevel 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