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Job Description

 

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.