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Project Manager - Labelling

Reference ID : 502MQ
Category :
  • Medical Devices
Date Posted : Nov 12, 2019
Job Location
:
  • Munster
- Limerick
Experience : 5+ Years
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
The Project Manager will design, proofread and coordinate the development and implementation of controlled documents applicable to Labelling, specifically Instructions For Use (IFU) manuals, Product Labels and Patient Cards.

Principal Responsibilities

Project Manager - Labelling

Headcount Engineering is seeking a Project Manager with labelling knowledge to join our client’s medical device manufacturing facility in Limerick.

The Project Manager will design, proofread and coordinate the development and implementation of controlled documents applicable to Labelling, specifically Instructions For Use (IFU) manuals, Product Labels and Patient Cards.

Responsibilities:

  • General project management: supervise projects through the development process; liaise with stakeholders, communicate progress, prioritise tasks and help to resolve issues or take corrective action as required
  • Participate as an SME (subject matter expert) in projects requiring input from a labelling assurance perspective.
  • Owner of Clinical Communications assigned CAPA’s and NCR’s: responsible for meeting all CAPA/NCR timelines and relevant actions and presenting progress at CAPA assignee meeting and CRB (CAPA Review Board).
  • Change control: write changes to create and update labels, IFU’s and Patient Cards using the electronic change control system and manage the changes through the various approval stages.
  • Process improvement projects: develop new processes where required and optimise current processes within the site quality system requirements.
  • Layout/Design: Work in In Design software to lay-out and produce IFUs and Patient Cards that conform to pre-determined sizes and standards; work in the company Labelling System to design, update and approve product labels.
  • Proofreading: proof various documents against their source files to ensure accuracy.
  • File transfer and management while maintaining strict version control: manage document files as they move through the process of review, approval, translation, printing and implementation.
  • Liaise with outside vendors - translation company and printing companies - providing them with files, clarifying any issues or question and ensuring their timelines adhere to project schedules.
  • Maintenance of the company Labelling System, including administration of user access and permissions for relevant personnel company wide and monthly archiving of product information.

Qualifications & Requirements

  • Third-level qualification in a relevant discipline
  • Previous experience of working within a quality system.
  • Excellent project management skills
  • Proficiency or ability to quickly learn multiple software packages and use them all interchangeably on a daily basis.
  • Highly developed file-management skills.
  • Ability to deal with constant change and multiple project revisions.
  • Ability to work remotely and communicate effectively via electronic and other methods.

To discuss the details of this position, please contact Mick on 086-0435195 or forward details in strict confidence to jobs@headcount.ie



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