Labeling Documentation Expert

2 days ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 14,00,000
Documentation Management Specialist Job Description

This role is responsible for overseeing the management of labeling databases, tracking issues, and maintaining QSR (Quality Systems Records) and related materials to support the creation/revision and control of customer labeling, specifications, and documentation for regulatory submissions, tenders, and commercial labeling.

Responsibilities:
  • Ensure documents supporting Labeling Development comply with ISO, cGMP, and FDA guidelines by working within established formats and templates.
  • Prioritize and manage Engineering Change Requests for Global Labeling & Packaging.
  • Collaborate with stakeholders on document reviews and provide assistance with inquiries and research.
  • Track documentation throughout the development process while adhering to strict timelines, maintaining revision control, change lists, and reviewer coordination.
  • Facilitate efficient change request consideration and approval processes, including stakeholder reviews and timely response on change management requests.
  • Communicate activity status, issues, and mitigation plans with key stakeholders effectively.
  • Identify areas for improvement and implement continuous improvement initiatives to maintain high quality, clarity, and consistency in all documents.


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