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Labelling Control Specialist

Req #: JR - 039288 Location Marsa, Il-Marsa, Malta Job Category: Quality Control Date Posted: 05/03/2021

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Labelling Control Specialist

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

The Control Specialist 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 create Baxter Labels at excellent quality.

  • The Control Specialist 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.

Essential Duties and Responsibilities. 

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

  • 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.

Education and/or Experience. 

Diploma or Advanced level of education is essential. Must be ICT proficient user.

Or 1 to 3 years’ experience working in the quality control department.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

039288

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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