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I have an urgent opening on Validation Lead with my client. Please Share me your resume along with full name, contact details, rate, and availability date. Need Lead Experiences & Need Locals Need Only GC or Citizens for this role Job Title Validation Lead Location New Jersey – Day1 onsite Duration 12+ Months Job Description: * Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. * You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. * Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems * Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation * Requirement Specification document review and approvals * System Implementation Plan Review * System Implementation Summary Report Review * Review and Pre-Approve ST/UAT Test Scripts in ALM * Create, Update RRA (Regulatory Risk Assessment) and obtain approvals * Post Execution Review and Post Approvals in ALM * gR Implementation Approvals * Retirement Plan Revew * Retirement Summary review Deliverables: * Requirement document * Validation/Test Plan * Requirement Traceability Matrix * Change Requests * Impact assessment document * Test/Validation Summary Report ”In case I missed your call, Email is the best way to reach me ” Thanks & Regards Adam Noel Technical Recruiter Phone: +1(614) 739 0208 Email : <mailto:a...@startechsinc.us> a...@startechsinc.us Website: <http://lqibq.smtptrack.com/tracking/qaR9ZGt1AmRjBQx4AmZ2Zmp5AGVmZlM5qzS4qaR9Zwt5BwOE> http://lqibq.smtptrack.com/tracking/qaR9ZGt1AmRjBQx4AmZ2Zmp5AGVmZlM5qzS4qaR9Zwt5BwSF Note : If you have received this mail in error or prefer not to receive such emails in the future, please reply with "REMOVE" in the subject line and the email id(s) to be removed. All removal requests will be honored ASAP. We sincerely apologize for any inconvenience caused -- You received this message because you are subscribed to "rtc-linux". Membership options at http://groups.google.com/group/rtc-linux . Please read http://groups.google.com/group/rtc-linux/web/checklist before submitting a driver. --- You received this message because you are subscribed to the Google Groups "rtc-linux" group. To unsubscribe from this group and stop receiving emails from it, send an email to rtc-linux+unsubscr...@googlegroups.com. To view this discussion on the web visit https://groups.google.com/d/msgid/rtc-linux/055801da456b%24efee9ae0%24cfcbd0a0%24%40startechsinc.us.
