RxCloud Services India PVT LTD
Computer System Validation Lead
RxCloud Services India PVT LTD, Raritan, New Jersey, us, 08869
Raritan, United States
| Posted on 07/15/2024Industry: Pharma/Biotech/Clinical ResearchWork Experience: 5+ yearsCity: RaritanState/Province: New JerseyCountry: United StatesJob Description
A Computer System Validation (CSV) Lead is responsible for ensuring that all computer systems and software used within a company, particularly in regulated industries like pharmaceuticals and medical devices, comply with relevant regulatory requirements and are functioning correctly. Here’s a detailed job description for a Computer System Validation Lead:Experience:Validating ERP to AWS Data migration process and Validating Data migration project.Experience in the Pharmaceutical, biotechnology, or medical device industry with 5+ years’ experience with System Development Lifecycle.5+ 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 and industry standards (i.e., GAMP).Experience in writing and executing documentation for all aspects of the validation deliverables like 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.Ability to provide Validation guidance, timely reviews, and escalations to Technology Quality management.
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| Posted on 07/15/2024Industry: Pharma/Biotech/Clinical ResearchWork Experience: 5+ yearsCity: RaritanState/Province: New JerseyCountry: United StatesJob Description
A Computer System Validation (CSV) Lead is responsible for ensuring that all computer systems and software used within a company, particularly in regulated industries like pharmaceuticals and medical devices, comply with relevant regulatory requirements and are functioning correctly. Here’s a detailed job description for a Computer System Validation Lead:Experience:Validating ERP to AWS Data migration process and Validating Data migration project.Experience in the Pharmaceutical, biotechnology, or medical device industry with 5+ years’ experience with System Development Lifecycle.5+ 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 and industry standards (i.e., GAMP).Experience in writing and executing documentation for all aspects of the validation deliverables like 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.Ability to provide Validation guidance, timely reviews, and escalations to Technology Quality management.
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