Validation Lead
Raas Infotek
Job Role: Validation Lead -CSV with Annex 11 Remediation Location: Raritan, NJ (Hybrid) Visa: USC/GC/H1B Job Description: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands‑on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. 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, System/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 TQ management -- Thanks Prashant Bansal Raas infotek corporation 262 Chapman road, Suite 105A, Newark, DE-19702 #J-18808-Ljbffr Raas Infotek
Vacancy posted 4 days ago
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