Job at a glance
· 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