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
