Experience with Validation of GEN AI solutions in GxP environment is key. Look for someone who has supported CSV AI projects
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
Numbers & Facts
Location
Raritan, NJ
Industry
Other/Not Classified
Company Size
100 to 499 employees
Skills
Acceptance Testingunmatched
Artificial Intelligence (AI)unmatched
Biotech and Pharmaceuticalunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
GxPunmatched
Industry Standardsunmatched
Leadershipunmatched
Medical Equipmentunmatched
Multitaskingunmatched
People Managementunmatched
Presentation/Verbal Skillsunmatched
Project Planningunmatched
Quality Assurance Methodologyunmatched
Regulatory Complianceunmatched
Requirements Managementunmatched
Riskunmatched
System Testunmatched
System Validationunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Test Scriptsunmatched
Testingunmatched
Time Managementunmatched
Traceabilityunmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
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