experience supporting validation of GxP GEN AI based solutions is a major plus
experience supporting mergers/acquisitions/divestitures is a major plus
Experience in the Pharmaceutical, biotechnology, or medical device industry
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
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 reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.
Strong verbal and written communication skills.
Ability to work as a team player, lead a team or accomplish tasks without supervision.
Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
Numbers & Facts
Location
Raritan, NJ
Skills
Acceptance Testingunmatched
Artificial Intelligence (AI)unmatched
Biotech and Pharmaceuticalunmatched
Communication Skillsunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
GxPunmatched
Medical Equipmentunmatched
Mergers and Acquisitionsunmatched
Multitaskingunmatched
Presentation/Verbal Skillsunmatched
Quality Assurance Methodologyunmatched
Regulatory Complianceunmatched
Requirements Managementunmatched
Riskunmatched
System Testunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Test Scriptsunmatched
Testingunmatched
Time Managementunmatched
Traceabilityunmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
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