CSV Consultant
E-Solutions
Job Title
Experience in the pharmaceutical, biotechnology, or medical device industry 2+ years’ experience with System Development Lifecyle 3+ years’ experience in Computer System Validation (Based on the role selected) Experience in FDA and/or global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance’s and industry standards (i.e., GAMP) 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 reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Vacancy posted 4 days ago
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