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· To establish validation strategies for 200+ GxP applications that will move to Windows 7 Work with issues related to IE and Google Chrome
· Develop test scripts Multiple sites
· Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
· Experience in Computer system validation.
· Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
· Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/validation reports.
· Experience in Software Development Lifecycle (SDLC).
· Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
· Experience in Change Control.
· Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)
· Experience is creation of SOPs.
· Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
· Hands on experience in HP Quality Center and QTP.
· Strong verbal and written communication skills.
· Able to work as a team player, lead a team or accomplish tasks without supervision