Job at a glance
Description: · 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