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Change Controller / Change Coordinator

Change Controller / Change Coordinator

NovintiX

5 years

0 Lacs

coimbatore tamil nadu india

Posted:4 days ago| Platform:

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Skills Required

controller support development maintenance compliance efficiency audit coordination documentation management initiation collaboration procurement planning procedural reporting traceability audits engineering mdr communication drive

Work Mode

On-site

Job Type

Full Time

Job Description

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.

Qualifications

Bachelor’s degree in Life Sciences, Engineering, or related field
3–5 years of experience in change control within the pharmaceutical industry
Hands-on experience with COMET or similar change management platforms (Windchill) etc.,
Strong understanding of GMP, GxP, and regulatory frameworks (e.g., FDA, EMA, MDR)
Excellent communication, coordination, and documentation skills
Ability to manage multiple stakeholders and drive timely execution

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Change Controller / Change Coordinator