Hybrid QA Lead: EU GMP & HPRA Compliance

RT.Lane; Dublin; Hybride; EUR 70 000 - 110 000; Plein temps

Résumé du poste

RT.Lane is seeking a Quality Assurance professional to serve as Qualified Person (QP) under EU GMP. The role ensures the QMS is fit for purpose, approvals of SOPs and GMP documents, and oversight of quality processes.

The successful candidate will have a BSc (Hons) in Science, at least 5 years' QA experience in the healthcare sector, and be prepared to work on a hybrid schedule with three onsite days at City West, Dublin.

Qualifications

• Minimum 5 years of experience in Quality Assurance in healthcare.
• Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
• Experience supporting HPRA inspections and regulatory interactions.

Responsabilités

• Manage QMS, ensure it is fit for purpose and approve SOPs and quality system documents.
• Maintain quality processes and provide QA expertise.
• Support HPRA inspections and prepare written responses to inspections.

Connaissances

Quality Assurance

GMP Knowledge

Regulatory Compliance

Documentation

Formation

BSc (Hons) in Science

Description du poste

RT.Lane is seeking a Quality Assurance professional to serve as Qualified Person (QP) under EU GMP. The role ensures the QMS is fit for purpose, approvals of SOPs and GMP documents, and oversight of quality processes.

The successful candidate will have a BSc (Hons) in Science, at least 5 years' QA experience in the healthcare sector, and be prepared to work on a hybrid schedule with three onsite days at City West, Dublin.