IRE_Qualified Person
Core
Certifying investigational medicinal products and ensuring compliance with EU GMP and regulatory requirements for clinical trial supplies.
Role type
Qualified Person (QP) for Investigational Medicinal Products
Builds
Clinical trial drug supplies for biopharma companies
Domain
Biopharmaceuticals / Clinical Trials / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU GMP knowledge, Quality systems expertise, Batch record review, Regulatory compliance, CAPA management, Change control, Supplier quality agreements, Audit support, Continuous improvement methodologies
Preferred skills
Lean Manufacturing, Sterile product experience, ATMP certification, Biologics certification
Technologies
EudraLex, EU Guidelines for Good Manufacturing Practice, Regulation (EU) No 536/2014
Responsibilities
Certify investigational medicinal products in accordance with Protocol and IMPD, Review batch documentation for cGMP/cGCP compliance, Lead or provide recommendations for CAPA, Support change control impact assessments, Provide audit support for Health Authority inspections, Mentor QA specialists
Seniority
Mid-Senior, Management level
