Remote Work - Need CSV Engineering Lead
Remote Work - Need CSV Engineering Lead
Steneral Consulting
United States
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
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.
- 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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