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Design Quality Officer

Req #: 1800078R_en
Location: Marsa MRS 3000, MT
Job Category: Quality
Date Posted: 4/2/2018 3:48:43 AM
Baxter International

Description

The Job

 

The Design Quality role will help Baxter in identifying and ensuring that the right information is delivered to our patients all over the globe. This is obtained by helping us creating Baxter Labels at excellent quality.

 

  • The Design Quality officer will ensure that all labels are updated according to the Regulatory Affairs requirements for each and every country Baxter supports.  
  • Design control and risk management activities applied to the labelling of medical packages.
  • Ensure that design control and risk management are performed in line with Baxter applicable procedures.
  • Responsible for executing day-to-day activities to support Global Labeling Operations.
  • Understand and leverage Baxter quality practices within your area of responsibility.

The job holder will be required to:

 

Artwork Control (Primary Function)

 

  • Carry out quality control of artwork to ensure high quality and compliant artwork is submitted.
  • Ensure that Design Artworks have been updated according to the mark up provided.
  • Ensure all typesetting of packaging components (including the text, graphics, chemical structures, bar codes etc…) are as per guidelines and standard.
  • Be proficient in using the software “Docuproof” in order ensure that artworks are updated correctly.
  • Have a basic knowledge of Adobe software’s like “Photoshop”, “Indesign” & “Illustrator”.
  • Proper Storage and archiving of documents as per local procedure.

Document Control (Supporting Function)

  • Trained in GDP, ability to maintain clear traceability with multiple revisions & multiple sign offs.
  • Work with labelling operations to finalize markups.
  • Ensure that documentation is in line with FDA Regulations.
  • Carry uploads of official documents for approval in Baxter Systems for document release.
  • Ensure that all packages are approved as per procedure and filed accordingly.

General Duties and Responsibilities

  • Ability to support and drive business targets associated with the labeling operations team (cycle time, accuracy, compliance).
  • Ability to support Global facilities/entities.
  • Ensure to maintain a 6S working environment in the working area.
  • When required, the incumbent shall provide support to the coordinator on project improvements
  • The incumbent is also responsible to ensure that all procedures related to his/her responsibilities are in line with corporate requirements and that any corrective actions triggered by Corporate/Internal/Other audits are always implemented within the established time frames.
  • The incumbent is also responsible to consider the aspects of Environment Health and Safety procedures to ensure that all activities within his role will support EHS targets and will not jeopardize the health and safety of employees and environment.
  • The incumbent must also ensure that all documentation and practices related to her role are in compliance with good laboratory and documentation practices.

 

 

 

Qualifications

Who you are?

 Experience of performing design control and document proof reading in accordance to ISO standards.

  • Exceptional organizational skills and ability to support business targets.
  • Experience in using IT Process Oriented Systems
  • Experienced in using “Docuproof” or similar software’s.
  • Be meticulous and attentive to detail.
  • Experience in quality control would be considered an asset.
  • Good interpersonal and communication skills.
  • Fluent in English (both written and verbal).
  • Fluency in any other language is considered as an asset.
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