| CSV Lead/Lead validation engineer :: Raleigh, NC(Contract position) :: (Onsite) at Raleigh, North Carolina, USA |
| Email: [email protected] |
| Please mention work authorization and current location of consultants while sharing the resume Only 10+ years candidates Local profiles will be preferred Hi, Hope you are doing well !! This is Raghwendra, and Im a Sr. Technical recruiter with E-Solutions., a diversity-inclusive global workforce solutions company headquartered in San Jose, California. I was going through your resume and wanted to share this amazing, fast-moving opportunity that I have, which seems like the perfect fit for a dynamic person like you. Heres the job description for your reference. Job Title : CSV Lead/Lead validation engineer Job Location: Goodlettsville, TN (Initial remote) Job Duration : Long term contract position Job Description :- CSV, Computer System Validation, Clinical Systems, periodic review and audit experience 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 We are looking for a pure validation resource with periodic review, audit experience. 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 (1.) To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents (2.) Co-ordination with On-Site Engineers and attending customer calls (3.) Raising risks, issues and escalation to senior management and customer (4.) To create all quality documents, collect metrics data and conducting Audits. To perform Value creation and KM activities. (5.) To create project plans and keep track of schedule for on time delivery as per the defined quality standards I'm interested in getting to know you better and introducing our company. Please let me know your availability today or this week for a quick call. Wishing you a wonderful day ahead! Sincerely, Raghwendra Singh Sr. Technical recruiter w: www.e-solutionsinc.com e: [email protected] Disclaimer: E-Solutions Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability. -- Keywords: information technology trade national Colorado Tennessee |
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| Thu Feb 29 20:39:00 UTC 2024 |