CSV Technical Lead

2 weeks ago

Raleigh, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • 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.
Requirements:
  • 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 a result of Change, Periodic Review, Audits.
  • 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.
  • Co-ordination with On-Site Engineers and attending customer calls.
  • Raising risks, issues and escalation to senior management and customer.
  • To create all quality documents, collect metrics data and conducting Audits. To perform Value creation and KM activities.
  • To create project plans and keep track of schedule for on time delivery as per the defined quality standards.

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