Technical Lead CSV Clinical Systems

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I believe you are a fantastic contact and would like to continue working for the below job Opening. Please send the resume to

Job Location: North Carolina Raleigh:

Remote ok (Yes / No) No

Project Duration 12 Months

Rate $60/hr

Job Title/Role Technical Lead

Mandatory 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
• To ensure process improvement and compliance and participate in technical design discussion and to review technical documents (2.) Coordination with OnSite 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