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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