| Requirement forSr. Computer System Validation||ONSITE||6 months||Skype at Remote, Remote, USA |
| Email: [email protected] |
| From: Mahima Raj, Tek Inspirations [email protected] Reply to: [email protected] Title: Sr. Computer System Validation (CSV) Specialist Duration: 6+ Month Contract Location: onsite, (Patriot Park North Carolina) Candidate must be local MOI: Phone then video Client: BIO-Pharma Manufacturing Experience with Moda ES (a MUST) Review of SOPs and other related administrative documents Batch review and manufacturing processes Must be familiar with quality reviews Excellent communication skills - significant writing Moda Engineer (Configuration) and Moda CSV CSV Manufacturing experience exposed / been involved in remediation correcting problems they read, research, and fix the problem. 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. Regards, Mahima Raj Lead IT Recruiter TEK Inspirations LLC : 13573 Tabasco Cat Trail, Frisco, TX 75035 Email: [email protected] Disclaimer: If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line to [email protected] . And mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience. Keywords: business analyst information technology Texas Requirement forSr. Computer System Validation||ONSITE||6 months||Skype [email protected] |
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| Mon Oct 28 20:21:00 UTC 2024 |