Validation Lead
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- 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.
• bility to lead a team. Ability to work with remote teams and support several changes/projects simultaneously.
• bility to provide Validation guidance, timely reviews, and escalations to TQ management.
• bility to work with global project teams during the initial project planning phases
• bility to provide guidance on validation strategy and be able to handle the highly fluid state of the project
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.
• bility to lead a team. Ability to work with remote teams and support several changes/projects simultaneously.
• bility to provide Validation guidance, timely reviews, and escalations to TQ management.
• bility to work with global project teams during the initial project planning phases
• bility to provide guidance on validation strategy and be able to handle the highly fluid state of the project
Vacancy posted 4 days ago
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