Sr. Labelling Engineer
Sr. Labelling Engineer
Vantive Healthcare Technologies Private LimitedEarly Applicant
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Job Description
- 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
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Key Skills
About Company
Vantive Healthcare Technologies Private Limited
Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.