Software Quality Engineer

Software Quality Engineer

Ref No.: GJGJ07866

Location: Limerick city, Limerick

Salary:

Experience required: 4 - 5 years

Job Type: Permanent



Summary: Software Quality Engineer with a minimum of 3 years software validation experience in an established QA function preferably in the healthcare industry. Limerick



Description:

Software Quality Engineer with a minimum of 3 years software validation experience in an established QA function preferably in the healthcare industry. Limerick

Responsibilities:

Co-ordination, implementation and active participation in the site validation programme for computer systems and cleaning

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 and prepare reports of executed protocol

Resolve and assist in the closure of deviation initiated during qualification execution

Initiate and implement change control activities in accordance with site procedures

Co-ordinate re-validation activities and generate SOP’s / other documentation as applicable

Conduct training in validation methodologies and related procedures as required.

Present validation systems at internal and external audits and support quality assurance programmes

Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.



Requirements:

Relevant 3rd Level Qualification in science or engineering .

A minimum of 3 years software 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,

Cleaning validation experience would be an advantage

Strong statistical skills and process capability are required along with excellent interpersonal, communication, facilitation and team working skills.