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LIMS Project Manager

Fabric
Pune6-9 LPA Posted 5 Feb 2026
FULL TIME
21 Cfr Part 11
Stakeholder Management

Job Description

Key Responsibilities:

  • Define project scope, objectives, timelines, and deliverables for pharmaceutical technology applications.
  • Develop detailed project plans, schedules, resource allocations, and risk mitigation strategies.
  • Track project progress using project management tools such as MS Project, Jira, Azure DevOps, or Smartsheet.
  • Conduct requirement-gathering workshops with business users.
  • Facilitate communication among technical teams, vendors, and business stakeholders.
  • Oversee system design, configuration, testing (IQ/OQ/PQ), and deployment activities.
  • Ensure adherence to GxP, 21 CFR Part 11, data integrity, and audit-readiness requirements.
  • Maintain project documentation including URS, FRS, validation documents, project charters, test scripts, and SOP updates.
  • Manage project budgets, cost forecasts, and financial tracking.
  • Coordinate with external software vendors, integrators, and support teams.
  • Review Statements of Work (SoWs), contracts, and vendor deliverables.
  • Identify project risks and implement mitigation strategies.
  • Lead issue resolution, change management, and impact assessments.
  • Prepare project dashboards, status reports, and executive presentations.
  • Ensure adherence to PMO standards and governance frameworks.

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