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Quality Operations Specialist - Commercial

Quality Operations Specialist - Commercial

PolyPeptideBraine-l'Alleud
30+ dagen geleden
Functieomschrijving

F or the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - Commercial.

The key tasks are (among others) :

As a QA referent for products, the major accountabilities includes to

  • Be the quality point of contact for customers and participate in the project team meetings
  • Manage customer requests, complaints, recalls and audits and organize the follow-up of findings
  • Manage and approve change controls, CAPAs & deviations linked to the products and inform management in case of any major quality or regulatory issue
  • Review and approve the documentation linked to the projects / products (MBR, analytical documentation, quality agreements, annual product review, …)

As a member of the QA operation team, the fonction also includes :

  • Write, review and approve documentation related to quality activities
  • Be the QA operations referent for Polypeptide projects, provide quality support to other departments and support the continuous quality improvement
  • Work within the quality and Regulatory team to maintain focused, effective progression in line with departement and Polypeptide objectives
  • What we expect from you is :

  • Master in Sciences  with minimum  5 year experience in QA in a GMP Environment
  • Fluency in  French and English  is mandatory (spoken and written English)
  • Excellent command of Word, Excel and PowerPoint
  • High  organizational skills , good interpersonal skills, flexibility in tasks and schedules
  • Sense of  responsibility , enthusiasm,  diplomacy  and team spirit
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    Quality Specialist • Braine-l'Alleud