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·         Argus Safety 7.0.x Upgrade

·         2+ years with validation of drug safety systems

·         Hands on experience with Argus 7 highly desirable

·         Experience with data migration validation/testing

·         8+ years experience in Quality and Compliance with substantial hands-on computer system validation experience

·         Prior experience leading/mentoring other validation professionals

·         Prior experience working with offshore teams

·         Experience in FDA regulated environment with good understanding of GxP related processes including Risk Based 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 with in Change Control processes.

·         Experience with various FDA regulations (e.g. 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.                                                    

·         Perform assessments of computer systems and processes at client sites (compliance with internal procedures, industry best practices, and regulatory requirements)

·         Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports