| MES Validation Engineer - ONSITE at Remote, Remote, USA |
| Email: [email protected] |
| From: Devakar Balachandran, KK Software Associates [email protected] Reply to: [email protected] Note: Please don't share OPT, CPT, H4EAD,TN, E3 and L2 Client: TCS Location: OMAHA / ONSITE JD: Role name: Analyst Role Description: Candidate should know about 21 CFR part 11, ALCOA, GxPKnowledge on MES Validation (FTPS, PMX)Aware of GDPR, SOX regulationsIO, OQ, PQ testing, Master Validation PlanTraceability MatrixData Migration projectsTypical Validation Deliverables in a CSV projectsERES Assessment, Audit Trail, Risk AssessmentAuthoring , reviewing of the Project deliverables.Hands on exp on Agile frameworkHands-on experience with any testing tool like HP ALM, JIRA, qTest, VERAStrong Understanding of Pharma concepts, CSV end to end lifecycle, GAMP 5Good understand of any of the foll areas.-HIPPA Compliance-SOX Compliance Competencies: EIS : MES Functional Consulting Experience (Years): 6-8 Essential Skills: Candidate should know about 21 CFR part 11, ALCOA, GxPKnowledge on MES Validation (FTPS, PMX)Aware of GDPR, SOX regulationsIO, OQ, PQ testing, Master Validation PlanTraceability MatrixData Migration projectsTypical Validation Deliverables in a CSV projectsERES Assessment, Audit Trail, Risk AssessmentAuthoring , reviewing of the Project deliverables.Hands on exp on Agile frameworkHands-on experience with any testing tool like HP ALM, JIRA, qTest, VERAStrong Understanding of Pharma concepts, CSV end to end lifecycle, GAMP 5Good understand of any of the foll areas.-HIPPA Compliance-SOX Compliance Desirable Skills: Candidate should know about 21 CFR part 11, ALCOA, GxPKnowledge on MES Validation (FTPS, PMX)Aware of GDPR, SOX regulationsIO, OQ, PQ testing, Master Validation PlanTraceability MatrixData Migration projectsTypical Validation Deliverables in a CSV projectsERES Assessment, Audit Trail, Risk AssessmentAuthoring , reviewing of the Project deliverables.Hands on exp on Agile frameworkHands-on experience with any testing tool like HP ALM, JIRA, qTest, VERAStrong Understanding of Pharma concepts, CSV end to end lifecycle, GAMP 5Good understand of any of the foll areas.-HIPPA Compliance-SOX Compliance Country: United States Keywords: hewlett packard trade national Tennessee MES Validation Engineer - ONSITE [email protected] |
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| Thu Sep 05 19:28:00 UTC 2024 |