05 Nov
|
VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE
|
Bengaluru
05 Nov
VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE
Bengaluru
- Own and manage end-to-end labelling activities starting from labelling strategy, planning. labels creation, release, labels verification and reporting.
- Manages, monitors, and controls labeling requests (within Change Control and labeling processes) from project notification through implementation.
- Perform labelling impact assessment.
- Create labeling project plan and schedule based on Labeling Request, obtain endorsement or agreement from stakeholders, hold accountability to the project plan, and escalate when deliverable dates are at risk or missed.
- Report status/issues/risks/escalations to project team and management.
- Lead labeling project meetings.
- Facilitate Labeling Input Review (i.e., meeting to review inputs and resolve conflicts between labeling content and labeling specification requirements).
- In collaboration with stakeholders, gather project requirements for labeling.
- Gather Inputs from stakeholders and create redline for IFU's and Labels
- Develop and Update IFU's and Labels for the product in scope.
- Approve final labeling artwork and/or final labeling specification
- Coordinate posting of eIFU's.
- Coordinate labeling obsolescence
- Coordinate with translation vendor for translation of manuals for the applicable languages in scope.
- Coordinate for In Country Reviews (ICR)
- Review and approve Labeling Verification plan, Test cases and Report
- Review and approve executed Labeling Test result
📌 Sr. Labelling Engineer (Bengaluru)
🏢 VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE
📍 Bengaluru