| Validation Engineer at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=173374&uid= From: James Smith, Rivago Infotech [email protected] Reply to: [email protected] Position: Validation QA Location: Santa Monica -CA(working 3 days a week from office) Number of Positions: 3 Job Responsibilities: Participate in meetings (status updates, aligning with stakeholders, resolving questions from cross functional teams) Change control CSV impact assessments (meeting with stakeholders for COI/COC systems) Review change control records o EBS change control records o Kite change control records (pre-approval and action items, completed action items, CC closure) Draft plans (Val plan or Computer System Change Assessment) and draft VSR Reviews (SDLC documents, post-executions, ECs) UAT sit-in sessions to ensure requirements are being followed if UAT is being leveraged for PQ, defect reviews/approvals Kite Konnect hotfixes/emergency fixes (review TIA, review evidence) Qualifications: Experience in startup or fast paced company, nice to have experience in cell therapy company Extremely detail-oriented Good in taking direction Effective communicator Good education Easy to work with personality Have at least 5+ years experience leading CSV projects from beginning to end, creating all SDLC documents, data migrations, system decommissioning Familiar with regulations 21 CFR Part 11, EU Annex 11, data integrity principles, GDP Thanks and regards. James Smith Talent Acquisition Lead P: +1 7867138348 E: [email protected] Keywords: quality analyst http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=173374&uid= |
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| 12:47 AM 30-Nov-22 |