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Empower CDS administration / support

Empower CDS administration / support

Fyntera IT ServicesGreenfield, IN, US
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Overview

Experience Range : 8-12 years

Qualifications

  • 3 years of hands-on experience in Empower CDS administration and support.
  • 3 years of experience on HPLC / UPLC and other analytical instrument integration.
  • 3 years of experience on Computer System Validation (CSV) and preparation of validation deliverables.
  • 1 year on GxP, 21 CFR Part 11, Annex 11, ALCOA principles, and Data Integrity requirements.

Key Responsibilities

  • Empower Administration & Support

    • Manage user accounts, access rights, roles, and privileges in Empower.

  • Perform system configuration, project management, and template / report customization.
  • Provide day-to-day L2 / L3 support for Empower users across QC / analytical labs.
  • Instrument Integration & Troubleshooting

    • Integrate lab instruments (HPLC, UPLC, Dissolution, UV, etc.) with Empower.

  • Troubleshoot connectivity, data acquisition, and communication issues between instruments and CDS.
  • Work with vendors (e.g., Waters, Agilent, Thermo) for resolution of technical issues.
  • System Validation & Compliance

    • Support Computer System Validation (CSV) activities for Empower and integrated lab systems.

  • Develop and maintain validation documentation (URS, FS, DS, IQ, OQ, PQ, Test Scripts, Traceability Matrix).
  • Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs.
  • Participate in audits and inspections, providing system and compliance evidence.
  • Compliance & Lifecycle Management

    • Maintain audit trails, backup, archival, and disaster recovery procedures.

  • Conduct periodic system reviews and ensure alignment with regulatory requirements.
  • Collaborate with QA, IT, and Lab teams to manage change control and deviations.
  • Training & Continuous Improvement

    • Train and mentor lab users on Empower functionalities and best practices.

  • Propose process improvements for data integrity, system efficiency, and compliance.

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    Administration Support • Greenfield, IN, US

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