| Validation Engineer at Remote, Remote, USA |
| Email: ajay.e@kksoftwareassociates.com |
|
https://rb.gy/r1ud0k https://jobs.nvoids.com/job_details.jsp?id=2010163&uid= From: AJAY, KK Software Associates ajay.e@kksoftwareassociates.com Reply to: ajay.e@kksoftwareassociates.com Role name: Engineer Role Description: CSV, Validation, Testing, Reports, Test, data validation, GAMP, CFR Competencies: EIS : Medical Device & Regulations Experience (Years): 8-10 Essential Skills: Computer System Validation Engineer Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. Validation Summary Reports, traceability analysis. Defect Logging and Tracking till closure. Desirable Skills: Role Computer System Validation Engineer Responsibilities- Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices. Author and update documentation to support ongoing CSV compliance. . Prepare or review all levels of validation documents including: o Validation (Strategy) Plans, User Requirement Specificationso Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs o Qualification Documents and Test Specifications (IQ, OQ, PQ) o Traceability Matrices, Risk Analysiso Validation Reports, Change Controls/ Events / Deviations etc Assess the impact of changes proposed to computerized systems and the level of change required. Provide validation strategy to the introduction of computerized systems. Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc) and management on all related matters on a regular basis. Country: United States Branch | City | Location: TCS - Dallas, TX Puerto Rico Puerto Rico, TX CSV, Validation, Testing, Reports, Test, data validation, GAMP, CFR - All Skill sets should be mandatory in resume Keywords: Texas Validation Engineer ajay.e@kksoftwareassociates.com https://rb.gy/r1ud0k https://jobs.nvoids.com/job_details.jsp?id=2010163&uid= |
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| 01:32 AM 13-Dec-24 |