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Quality Assurance Specialist

baxter · S. Vittore

Nouveau
🇬🇧 English
Good Documentation Practices Good Manufacturing Practices ISO 13485

Description du poste

About the role

As a Quality Assurance Specialist at Baxter, you will ensure plant activities comply with GMP requirements and company quality policies, working closely with cross‑functional teams to drive investigations, corrective actions, and supplier qualification.

Key responsibilities

  • Create, review, distribute and archive quality records following Good Documentation Practices.
  • Lead non‑conformity investigations, develop corrective action plans, and implement sustainable solutions.
  • Drive supplier qualification and monitor supplier quality to meet Baxter’s expectations.
  • Support internal and external audits, ensuring compliance and inspection readiness.
  • Provide training and coaching on quality responsibilities and standards.
  • Maintain and update quality policies, procedures, and the Quality Manual.
  • Manage electronic quality documentation processes for accuracy and accessibility.
  • Collaborate with site departments to keep processes current and effective.
  • Promote continuous improvement to enhance efficiency and overall quality performance.

Required profile

  • Experience with Quality Management Systems in pharmaceutical or medical device environments.
  • Understanding of GMP and ISO 13485 requirements.
  • Degree in Engineering or a scientific field, or equivalent experience.
  • Proven track record managing investigations and corrective actions.
  • Strong communication, collaboration, and problem‑solving skills.
  • Good level of English and Italian.

Required skills

  • Good Documentation Practices (GDP)
  • Good Manufacturing Practices (GMP)
  • ISO 13485

What we offer

  • Competitive salary based on experience.
  • Purposeful work supporting healthcare professionals and patients.
  • Collaborative culture focused on teamwork and continuous improvement.
  • Career development opportunities within a global healthcare leader.
  • Opportunity to lead meaningful projects and drive site‑wide improvements.

Questions fréquentes

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Source : ats:workday

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baxter

S. Vittore