Change Coordinator

2 weeks ago

Coimbatore, Tamil Nadu, India NovintiX Full time ₹ 5,00,000 - ₹ 12,00,000 per year

About Novintix :

NovintiX
is a fast-growing engineering and digital transformation consultancy serving top Life Sciences, MedTech, and Healthcare clients across the US, Ireland, and Europe. We specialise in delivering high-impact digital programs, engineering services, and talent solutions that accelerate innovation, efficiency, and compliance.

Role Summary

The Change Controller will support the development, implementation, and maintenance of global change control processes to ensure regulatory compliance, operational efficiency, and audit readiness. This role involves cross-functional coordination, documentation accuracy, and timely execution of change control activities using platforms like COMET (Change Control Management & Execution Tool) & Windchill etc.,

Key Responsibilities

Change Control Initiation & Documentation

  • Create and manage change control records in COMET / Windchill based on SME inputs.
  • Ensure clarity in describing change scope, impacted functions/sites, risks, and stakeholder involvement
  • Prepare and maintain change control plans aligned with regulatory and operational standards.

Pre-Change Coordination

  • Organize and facilitate pre-change alignment meetings.
  • Prepare slide decks and summaries for Change Control Board (CCB) endorsement.
  • Identify assessors and approvers and ensure their alignment before initiation.

Stakeholder Collaboration

  • Liaise with QA, Procurement, Planning, R&D, and other impacted teams to ensure smooth implementation.
  • Track and communicate status updates to stakeholders throughout the change lifecycle.

Execution & Follow-Up

  • Monitor timely completion of assessments, reviews, approvals, and implementation tasks.
  • Send reminders and coordinate meetings to ensure due dates are met.
  • Manage amendments or extensions as needed, ensuring procedural compliance.

Audit Readiness & Reporting

  • Maintain documentation and traceability to support internal and external audits.

Ensure global change control records are complete, accurate, and compliant.

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