Face To Face : CSV Engineer || Raritan, NJ at Raritan, New Jersey, USA |
Email: [email protected] |
Role - CSV Engineer Location - Raritan, NJ (Hybrid) Face To Face Rate: 38/hr 3-7 years of relevant experience; can work independently and guide mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation 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 (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, systems and UAT test scripts and Test procedures. Ability to Review Automated Test script 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. Hands on experience with validation of Data Solutions is preferred. To develop and deliver detailed solutions through consulting project activities. To perform qualitative and or quantitative analyses to assist in the identification of client issues and the development of client-specific solutions To work with the team in implementing the solutions To develop good practice and Serve as a subject matter expert. To design and structure reports and presentations that are appropriate to the characteristics or needs of the audience To develop knowledge base by staying updated on industry best practices ,emerging trends and creating re-usable components. Thanks and Regards, Deepansh Saxena Senior Technical Recruiter, Zodiac Solutions Inc Email: [email protected] https://www.linkedin.com/in/deepansh-s-0aa290199/ Office: www.zodiac.solutions.com Note: Due to high call volume if I miss your call, email and LinkedIn is the better way to reach me -- Keywords: quality analyst information technology New Jersey Face To Face : CSV Engineer || Raritan, NJ [email protected] |
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Fri Sep 20 01:01:00 UTC 2024 |