Quality Assurance Release Supervisor

Baxter SA BEL (Lessines, België) 24 dagen geleden gepost

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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

Summary

Responsible for the management and control of finished product release activities (sterile drugs and medical devices).

Lead finish product release process improvements, both locally as globally driven initiatives.

Essential Duties and Responsibilities

  • Responsible for the management and control of finished product release activities (sterile drugs and medical devices).
  • Responsible for the coordination and planning of batch file review activities of the complete Quality Assurance Release team.
  • Monitor and improve the release performance of the Quality Assurance team. Responsible for KPI (Key Performance Indicators) of both the release process (sterile drugs and medical devices) and release team to be submitted to the Region/Global.
  • Facilitate interactions of and ensure appropriate linkage with different stakeholders: Manufacturing, Supply Chain, Contract Manufacturing Organizations/3rd party suppliers, Product development and Quality Assurance team.
  • Assure establishing all regulatory aspects (documentation and procedure updates, quality agreements, …).
  • Support external and internal audits with release activities in scope, as auditee and auditor (internal audit only).
  • Participate in quality training development and deliver quality training like GMP.
  • Participate in the Enterprise Management Systems and 6S implementation
  • Lead finish product release process improvements. Implement both locally as globally driven initiatives for improvements.

Qualifications

  • Minimum bachelor’s degree of science, bachelor’s degree of engineering or equivalent acquired through relevant experience.
  • 3 to 5 years of experience in a pharmaceutical industry
  • Fluent in English and French
  • Dedication to Quality. Knowledge of GMP (EudraLex Volume 4) and applicable Medical Device directives and regulations
  • Excellent knowledge of Quality Systems and compliance. Experience in project management.
  • Good and effective communication skills
  • Experience in people management: interact efficiently with team members and all the different stakeholders (both locally and globally).
  • Team spirit minded.
  • Dynamic and motivated.
  • Is very well organized, has an analytical and critical mind, is results oriented.
  • Ability to work in a changing environment.
  • Accountable and integer

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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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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Quality Assurance Release Supervisor

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