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*Title – Senior Tester/validation QA* *Location - Irvine, California* *Duration: 6-12 Months* Embedded product testing, computer system validation in addition to 21CFR part 11 Experience: Minimum 3 years • Experience in validating the Laboratory Equipment, Computerized System and Manufacturing Equipment. • Should have system verification knowledge. · Extensive validation experience in 21 CFR Part 11. • Good understanding of GxP standards. • Well acquainted with all the phases of Validation Life Cycle (VLC). • Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications). • Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix and Validation Summary Report (VSR). • Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions. • Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process. • Extensive experience in performing Risk Assessment and Failure Modes and Effects Analysis (FMEA). • Extensive experience with testing tools like HP Quality Center · Good communication skills and English fluency. -- 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 http://groups.google.com/group/usitcv. For more options, visit https://groups.google.com/d/optout.
