Experience in the Pharmaceutical, biotechnology, or medical device industry.
2+ years' experience with System Development Lifecyle.
3+ years' experience in Computer System Validation (Based on the role selected).
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 reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and 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.
Numbers & Facts
Location
Raritan, NJ
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Skills
Acceptance Testingunmatched
Biotech and Pharmaceuticalunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Consultingunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
GxPunmatched
Industry Standardsunmatched
Medical Equipmentunmatched
Multitaskingunmatched
Presentation/Verbal Skillsunmatched
Quality Assurance Methodologyunmatched
Regulatory Complianceunmatched
Requirements Managementunmatched
Riskunmatched
System Testunmatched
System Validationunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Test Scriptsunmatched
Testingunmatched
Traceabilityunmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
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