IRE_Qualified Person

Clinical Experience desirable but not essential.

At least 3-5 years’ experience in a quality management role in the Pharma industry.

Steriles experience is desirable but not essential.

Extensive quality systems and quality operations experience.

Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

The Qualified Person is responsible for certifying investigational medicinal products in accordance with requirements of Protocol, Investigational Medicinal Product Dossier (IMPD) and Product specification File (PSF)

The compliance of all certified batches to EU Directives, Annex 16 and Annex 13 / Detailed Commission Guidelines where applicable for Investigational Medicinal Products (IMPs).

Provide the Quality management team direct support and guidance in all quality matters as directed by Head of Quality to ensure that Quality operations meet the requisite safety, quality, and cGMP requirements.

Participate in cross functional teams to provide consultative support on quality related issues.

Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs).

During review, the QP ensures that all regulatory requirements are met regarding importation, testing and the release of clinical product to third party sites.