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Validation - Auditing, Document Professional/Consultant
· Knowledge with computer system validation experience.
· 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).
· Knowledge in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
· Experience is creation of SOPs.
· Knowledge of FDA guidance’s and industry standards (i.e., GAMP).
· Strong verbal and written communication skills.
· Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports.