| Technical Validation Lead (CSV, Clinical Systems (CDMS)) at Raleigh, North Carolina, USA |
| Email: [email protected] |
| From: Benny Wilson, W3GLOBAL INC [email protected] Reply to: [email protected] Hi All, Greetings from W3Global Inc!! Job Title : Technical Validation Lead (CSV, Clinical Systems (CDMS)) Employment Type : Contract to Hire Location : Raleigh, NC, US (Onsite) Experience: 10+ Years Must... Job Description Must Skills: CSV, Computer System Validation, Clinical Systems (CDMS) Keywords : CSV, Computer System Validation, Clinical Systems, Safety Systems, Infrastructure Qualification, 21 CFR part 11, GAMP 5, ICH, EMEA, MHRA regulations Roles and Responsibilities Must Have 10 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality Support Risk assessment Document Regulatory Requirements and Review Specification documentation (viz. User Stories, URS, FRS) Review and final Approval of requirements, Technical Design and Solution Architecture Plan, IQ, OQ and PQ pre and post execution documents Lead, Write, Review/ Approve Discrepancy Logs (final dispositions) Lead, Write, Review / Approve Requirement Traceability Matrix (RTM) and Validation Summary Reports Good to Have (secondary skills) Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification Conduct Periodic Reviews of GxP Apps as per the frequency stated in the governing SOP and write Periodic review reports and Review and Approve Periodic Review Reports Tracks the Periodic review findings and open CAPA s to a closure Review and Approve System Support and Operations plan Participate in and support Audits. Contribute and Review/ Approve Decommissioning Plans & Decommissioning Reports Contribute, Review/ Approve deliverables for Change Management Support Maintain validation documentation throughout product lifecycle viz.as a result of Change, Periodic Review, Audits Communication Immaculate communication and handles multiple clients/ projects Works in Consulting capacity Please let me know your interest and let's keep in touch until we make this happen Referrals appreciated and welcomed. Thanks & Regards, Benny Wilson Recruiter W: +1 (469) 287-8474 E: [email protected] A: 1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034 Keywords: North Carolina |
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| Mon Feb 12 21:46:00 UTC 2024 |