Contract Role: Validation Lead(Computer System Validation – GenAI, Agentic QMS) at Raritan, NJ (Onsite - Hybrid)

Validation Lead(Computer System Validation – GenAI, Agentic QMS) Raritan, NJ (Onsite - Hybrid) Long Term Contract Job Details • :Experience in the Pharmaceutical, biotechnology, or medical device industr • yExperience with Validation of GEN AI solutions in GxP environment is ke • y2+ years’ experience with System Development Lifecyl • e3+ years’ experience in Computer System Validation 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 Report • sExperience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs • .Strong verbal and written communication skills • .Ability to lead a team. Ability to work with remote teams and support several changes/projects simultaneously • .Ability to provide Validation guidance, timely reviews, and escalations to TQ management • .Ability to work with global project teams during the initial project planning phase • sAbility to provide guidance on validation strategy and be able to handle the highly fluid state of the projec t