Validation Lead(Computer System Validation - GenAI, Agentic QMS
Job Description
Job Title: Validation Lead(Computer System Validation – GenAI, Agentic QMS)
\n
Location: Raritan, NJ (Hybrid - Onsite role)
\n
Duration: 6+ Months
\n
\n
In addition to validation and regulation experience, the resource should have the following experience:
\n
\n
Experience with Validation of GEN AI solutions in GxP environment is key.
\n
Look for someone who has supported CSV AI projects
\n
\n
Job Details:
\n
• Experience in the Pharmaceutical, biotechnology, or medical device industry
\n
• 2+ years’ experience with System Development Lifecyle
\n
• 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.
\n
• Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
\n
• 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
\n
• 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.
\n
• Strong verbal and written communication skills.
\n
• Ability to lead a team. Ability to work with remote teams and support several changes/projects simultaneously.
\n
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
\n
• Ability to work with global project teams during the initial project planning phases
\n
• Ability to provide guidance on validation strategy and be able to handle the highly fluid state of the project