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Quality Assurance / Back-up RP

Quality Assurance / Back-up RP

Katoen NatieBeringen, BE
Il y a 1 jour
Description de poste

Job description

We are seeking a dedicated and detail-oriented Quality Assurance & Compliance Officer to join our Healthcare Operations team. This hybrid role combines the responsibilities of a QA Officer with those of a Backup Responsible Person (RP), ensuring full compliance with Good Distribution Practices (GDP) and maintaining a robust Quality Management System (QMS) across our operations.

Responsibilities :

  • Maintain and improve the Quality Management System, including documentation practices, CAPAs, trend analysis, and internal audits.
  • Lead and support quality inspections, audits (internal, customer, regulatory), and self-inspections.
  • Review and approve quality-related documents, including SOPs, protocols, and specifications.
  • Conduct risk assessments and root cause analyses for quality and logistics complaints.
  • Train QC personnel and contribute to the development of training materials and quality guidelines.
  • Monitor third-party service providers for compliance with quality standards.
  • Report on quality system performance, regulatory inspection outcomes, and product / process risks.
  • Stay current with industry best practices and regulatory changes.
  • Assessing customer requirements and ensuring that these are met.
  • Act as a backup RP : Compliance with GDP guidelines (5 November 2013) for the storage and transport of medicinal products. Ensuring traceability, managing recalls, handling deviations, and overseeing product returns and destruction.

Your profile

  • Master’s degree in Pharmaceutical Sciences, Industrial Pharmacy, Veterinary Sciences, Chemical or Biomedical Sciences
  • A first experience in GxP environments and quality systems
  • Professional English required, Dutch is a strong plus
  • High attention to detail, integrity, and a proactive, problem-solving mindset
  • Required experience2 years We offer

  • Opportunity to learn and develop skills doing and an exciting job an environment with a no-nonsense culture
  • A competitive salary in accordance to knowledge and experience
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    Quality Assurance • Beringen, BE