Reference: Software QA
Closing Date: 22 Dec 16
Salary (£): Competitive
Client is working to harmonize their quality systems, and they will be consolidating down to software platforms. Validant is augmenting their QA team and ensuring software validation compliance. This project will entail reviewing and approving software deliverables for validation, authoring quality system assessments, and acting as mentors to IT project teams.
Executes a defined validation strategy against the policies and procedures governed by Client's Software Development Lifecycle Management methodology (SDLM).
Focus on shaping the validation deliverables as defined by the SDLM procedures. The content of the validation deliverables will be provided by the (SME's) Subject Matter Experts from Business and Information Technology.
Serve in active role to gather information from respective SMEs, identify any gaps from a regulatory perspective that there may be in the content provided and complete all activities which ensure finalization and approval of validation records demonstrating compliance with SDLM requirements.
· Experience with validation and implementation of large computer systems automating Quality System processes for medical device companies. SAP experience preferred.
· Experience with workflow management tools
· BS degree in Computer Science, Software Engineering, or related field.
· Minimum of 6 years related experience in software validation
· Experience in validation in the medical device industry or other FDA-related/cGMP environment.
· Working experience with FDA software guidelines.
· Experience in writing validation test documents.
· Proficient at MS-Word, Excel, Access
· Strong communication (written/verbal) skills.
· Ability to generate and maintain accurate records
Unit 4 Emmett House Barrack Square Ballincollig Cork
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