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Computer System Validation of Lab Information Management System - LIMS at Raritan, New Jersey, USA

Email: [email protected]

Hello, Role - CSV Engineer Location - Raritan, NJ(Hybrid 3 days a week) Skills- Computer System Validation, GxP Regulations SS- Validating Lab Information Management System - LIMS, LIMS Rollover 10years experience in Computer System Validation of Lab Information Management System - LIMS Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC Application of FDA guidances and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams Expertise in documentingguiding various SDLC Deliverables including Requirements Specification User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation StrategyTest Planning, ValidationTest Summary, Requirement Trace Matrix. Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Ability to work with project team to facilitate interaction between Project team and Business Stake holders Ability to manage and provide guidance train the team on Policies, end to end SDLC Process, Procedure and Tools Trains the project team on the relevant procedures associated with different SDLC processes and Tools Strong in Project Management tools like JIRA Manage Project priorities based upon identified risks. Domain Competencies (APPS)-Pharma Validation & Verification-Computer System Validation (CSV) Thanks & Regards Prameela Sr Technical Recruiter | FISEC GLOBAL INC 9255976011 ext 511 fisecglobal.net/  prameela @fisecglobal.net linkedin.com/in/-prami0116 Keywords: New Jersey Computer System Validation of Lab Information Management System - LIMS [email protected]

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01:42 AM 26-Feb-25

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Location: Raritan, New Jersey