Quality Assurance / Back-up RP

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

Required experience2 years We offer