Hello, Greetings form eTeam We have an urgent need for *a * *Validation Engineer*-for one of our clients in *Foster city, CA. *Please go through the below requirement if you are open for projects and if interested in the below requirement, Please respond back with latest resume along with details ASAP.
*Role: Validation Engineer Location: Foster city, CA Duration:- 6+ Months* *Job description:-* · Has prior experience in validation of Oracle EBS system, in particular PTM and OTC modules. · Must possess excellent technical writing, documentation and communication skills · Knowledge of FDA requirements for computerized systems, including experience interpreting 21 CFR Part 11 and EU GMP Annex 11 requirements · Knowledge and experience with the GAMP approach to computer system validation lifecycle management · Strong attention to detail, quality oriented · Demonstrated breadth and depth in information technology and/or pharmaceutical industry experience with exposure to a broad range of GxP validation activities such as document control, computer systems, vendor assessment, and change control. · Has a strong working knowledge of the testing process, designing test scenarios and test scripts, including of understanding of various software quality practices, with the ability to learn and apply new and emerging concepts very quickly. · Demonstrates an understanding of application development methods, the project management processes, as well as the fundamentals of requirement specification, design, and development/configuration · Can quickly attain a broad understanding of the environment at Gilead, to apply an understanding of the interoperability of systems and technologies to the testing/validation effort *Roles & Responsibilities* · Validation of of Oracle EBS system · Assist in developing and documenting and reviewing User, Functional and Design requirements; traceability matrix documentation; Infrastructure Qualification and change control · Author Validation Plans, System Risk Assessments, Installation, Operational and Performance Qualification protocols (OQ/PQ) · Execute test protocols (OQ/PQ), perform/support system development, testing and validation activities per current Standard Operating Procedures and guidelines. · Coordinate validation activities including test execution and status reporting, deviation documentation and resolution. · Author Test and/or Validation Summary Reports; · Collaborate with Technical team, Business stakeholders, QA specialists in Quality/Compliance and ensure GxP systems are validated and in compliance. · Participates in the identification of risks and the development of mitigation strategies for project. Thanks & Regards, Gaurav Jain - Sr. Technical Recruiter <http://www.eteaminc.com/> Efficiency.Synergy.Expertise. eTeam Inc- "ACCELERATED HIRES" 1001 Durham Avenue, South Plainfield, NJ 07080 Desk: 732-248-1900 x432, Fax: 908-757-0800 (F) E-Mail: *gj...@eteaminc.com* <r...@eteaminc.com>| *www.eteaminc.com* <http://www.eteaminc.com/> -- You received this message because you are subscribed to the Google Groups "USITCV" group. To unsubscribe from this group and stop receiving emails from it, send an email to usitcv+unsubscr...@googlegroups.com. To post to this group, send email to usitcv@googlegroups.com. Visit this group at https://groups.google.com/group/usitcv. For more options, visit https://groups.google.com/d/optout.
