| Validation Engineer Lead at Raritan, New Jersey, USA |
| Email: [email protected] |
| From: Vinay Shukla, Resource Logistics Inc. [email protected] Reply to: [email protected] Job Title: Validation lead Job Location: Raritan, NJ (Hybrid), United States JOB DETAILS: Experience in the Pharmaceutical, biotechnology, or medical device industry 5+ years experience with System Development Lifecyle 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 s 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., Keywords: quality analyst New Jersey Validation Engineer Lead [email protected] |
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| Wed Aug 21 05:11:00 UTC 2024 |