GxP Senior Consultant

4 weeks ago


Raleigh, United States eTeam Full time

•Strong Hands-On experience in GxP Validation Testing •12+ Yrs of experience is must •Hands on experience in IQ, OQ, PQ protocol creation and review •Good Knowledge on CFR Part11, Quality management system, Veeva or any DMS use •Hands on expertise in creating and reviewing Validation Planning, Validation summary, Trace report, Impact Assessment, SOP Creation/review •Hands on Experience in SAP Testing Functional knowledge in various domains like O2C, PTP, RTR, STS •Experience in MF ALM, JIRA •Strong communication skills •Plan and strategize project execution •Gather requirements and perform high level analysis •Work with Business and support for PQ •Co-ordinate and channelize/route team members to appropriate PoC from the customer end & unblock any hurdles


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    3 weeks ago


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