CSV Engineer - Katalyst Healthcares & Life Sciences
Plainsboro, NJ 08512
About the Job
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 of 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.
Source : Katalyst Healthcares & Life Sciences