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Quality Operations Specialist - Commercial
PolyPeptideBraine-l'Alleud30+ dagen geleden
FunctieomschrijvingWrite, 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 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
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 :
What we expect from you is :
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Quality Specialist • Braine-l'Alleud