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Computer System Validation (CSV) Lead Engineer Position in Raleigh, NC, USA (Onsite - Locals Preferred) at Raleigh, North Carolina, USA
Email: [email protected]
From:

Pavan Kumar,

Yochana IT

[email protected]

Reply to:   [email protected]

Note from Client: Local to North Carolina consultants preferred.

Skills Required

:
   CSV, 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

(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

Keywords: information technology Colorado
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Thu Feb 08 22:28:00 UTC 2024

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