| CSV--Validation engineer at Remote, Remote, USA |
| Email: [email protected] |
| Computer System Validation Engineer Contract C2C/w2/1099 Local to NC only with DL Must be able to get to (Patriot Park North Carolina) work is onsite - NO REMOTE Primary Responsibilities: Work in computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems. Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies). Review and (remote) execution Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations. Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols. Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols. Assist investigate and resolve Deviations, CAPA investigations and other potential issues. Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls. Available to attend meetings as necessary Periodic Review activities Ability to manage three to four active projects Applications to support MODA (EM/ES) SAP, ProcessPad, ASCTrac, LIMS, BMRAM ELN, ComplianceWire Adobe sign Jira Education BS/BA required in a related field. Kind Regards, Syeda Hajra | Absolute IT | Senior Technical Recruiter 116 Village Blvd Suite 200 Princeton New Jersey 08540 Absolute IT [email protected] https://www.linkedin.com/in/syeda-hajra-a96813245/ www.absoluting.com -- Keywords: business analyst information technology wtwo North Carolina CSV--Validation engineer [email protected] |
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| Tue Oct 29 18:54:00 UTC 2024 |