CSV Lead Remote Location
Raritan NJ Job Description: >> Experience in the Pharmaceutical and biotechnology industries with LIMS Labvantage related System Development Lifecycle in Computer System Validation. >> Experience in FDA andor Global regulated environment with a good understanding of GxP standards and Risk-based validation. >> Knowledge of FDA guidance documents and industry standards (i.e., GAMP). >> Experience in writing and executing documentation for all aspects of the validation deliverables, including Requirements, ComplianceValidation Plans, test protocols, Test Summary reports, and ComplianceValidation Reports. >> Experience in reviewing system test and user acceptance test scripts, Traceability matrix, and Design Specs. >> Experience in QA Methodologies, designing, reviewing, and approving Test Plans, systems, UAT test scripts, and Test procedures. >> Ability to review Automated Test scripts. >> Strong verbal and written communication skills. >> Ability to work as a team player, lead a team or accomplish tasks without supervision. >> Ability to work with remote teams and support several changesprojects simultaneously. >> Ability to provide Validation guidance, timely reviews, and escalations to TQ management. Requirements: >> LIMS - Lab Vantage & CSV