Validation Lead

- Validation Lead(Computer System Validation GenAI, Agentic QMS)
Location - Raritan, NJ(Hybrid)
$50/hr on w2

Job Details:
" Experience in the Pharmaceutical, biotechnology, or medical device industry
" 2+ years experience with System Development Lifecyle
" 3+ 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 Reports
" Experience 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 phases
" Ability to provide guidance on validation strategy and be able to handle the highly fluid state of the project