Steneral Consulting

Remote Work - Need CSV Engineering Lead

Steneral Consulting United States
Steneral Consulting

Remote Work - Need CSV Engineering Lead

Steneral Consulting United States
1 month ago 59 applicants

See who Steneral Consulting has hired for this role

100% remote, client is in CST

Need valid LinkedIn

Need Independent candidates

Must Have Veeva Implementation Experience.

This leadership position reports to the CSV Manager and Operations and will work closely with the other members of the organization to meet the program's goals.

Responsibilities

  • CSV Engineering, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
  • Provides IT CSV oversight for GXP computerized systems and applies risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP.
  • Provides IT CSV oversight of deviations, CAPAs, and change controls related to GXP computerized systems.
  • Review and create validation documentation - such as user requirements functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments and VSR’s.
  • Analyses, develops, tests, and deploys configuration, workflow, and/or reporting to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized system.
  • Effectively identifies and resolves system issues and appropriately communicates gating items to senior management and stakeholders.
  • Review and audit CSV for IT systems according to 21 CFR Part 11, Annex 11, and other regulatory requirements.
  • Participate in the development and improvement Quality Assurance programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
  • Supports the external audit program for vendors related to GXP computerized systems.
  • Participates in cross-functional project teams.
  • May support and interface with regulatory agencies as required in support of regulatory agency inspections.

Job Skills Requirements

  • Bachelor’s degree or equivalent experience.
  • Substantial experience in CSV of GCP/GLP/GCLP/PVQA eSystems.
  • Prior experience in leading or managing CSV projects.
  • Experience supporting regulatory inspections.
  • Experience with JDE and Veeva preferred

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Engineering and Information Technology

  • Industries

    IT Services and IT Consulting

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