Demo

Validation Lead

Katalyst HealthCares & Life Sciences
Indianapolis, IN Contractor
POSTED ON 12/30/2024 CLOSED ON 1/30/2025

What are the responsibilities and job description for the Validation Lead position at Katalyst HealthCares & Life Sciences?

Responsibilities

  • Work in partnership with the Global IT team and site representatives to understand business needs and implement innovative solutions to add value to the site while maintaining computer systems in a validated state.
  • Quarterly Audit Trail review of IPM systems- FOP, DSA, CVM, and PMX.
  • Periodic Review of PMX- March and Oct.
  • DI Documentation Project- Update security plans and any other documentation.
  • Life Sciences: Computer System Validation, Healthcare: Pharmacy, Communication, Regulatory IT Compliance.

Requirements:

  • Quarterly Audit Trail review of IPM systems- FOP, DSA, CVM, and PMX
  • Periodic Review of PMX- March and Oct.
  • DI Documentation Project- Update security plans and any other documentation.
  • SIA of LQPs and other Global documents.
  • ARR for the computer systems.
  • Assist with any CSV project in the Compliance Map as needed.
  • Periodic review of CVM and DSA
  • Risk Management, Supplier evaluation, assessment, and auditing experience is highly desirable.
  • Experience of working in virtual teams across different cultures and geographies.
  • Experience of working with cloud-based technologies is desired.
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