CSV Consultant
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Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
Ex-J&J preferred
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 guidances 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
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 guidances 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
