What are the responsibilities and job description for the Excellent CSV Consultant Role || Raritan, NJ(Hybrid) position at AppLab Systems, Inc?
Role - CSV Consultant
Location - Raritan, NJ(Hybrid)
Mode Contract || Long Term
Job Details
Ex-Pharmaceutical 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 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
Saurav Kumar
APPLAB Systems
Saurav.kumar@applabsystems.com
609-629-2048 Ext 551
4365 Route 1 South, Suite 105
Princeton, NJ -08540
www.applabsystems.com
Location - Raritan, NJ(Hybrid)
Mode Contract || Long Term
Job Details
Ex-Pharmaceutical 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 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
Saurav Kumar
APPLAB Systems
Saurav.kumar@applabsystems.com
609-629-2048 Ext 551
4365 Route 1 South, Suite 105
Princeton, NJ -08540
www.applabsystems.com