Technical Lead (CSV, Clinical Systems) – Fully Onsite
Job Description
Job Title : Technical Lead (CSV, Clinical Systems) – Fully Onsite
Employment Type : Contract to Hire
Location : Raleigh, NC, US
Remote : No
Job Description
Must Skills: CSV, Computer System Validation, Clinical Systems
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