Quality Assurance

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 experience- 2 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
- Contact person- Liesbeth Bogaert- Application- CV + motivation