CSV Consultant

Responsibilities:

• 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

Requirements:

• 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