EU Qualified Person

Job description

We are looking for a EU registered Qualified Person (QP) to assist in the build out of a new Clinical Packaging facility just outside of Amsterdam.

The Role

An exciting opportunity has arisen for a Qualified Person (QP) to join a Global Clinical Packaging and Distribution company. As a QP, you will have a critical role in assuring quality and compliance for the site through the certification and release of manufactured, assembled or imported investigational medicinal products (IMPs). This role can be considered part time, contract or permanent.

Key Responsibilities

Undertake QP responsibilities for certification and release of intermediate and finished IMP in compliance with GMP, Manufacturing Authorisation, Clinical Trial Application and regulatory requirements.

Interpretation and communication of GMP regulatory requirements to staff and customers including Investigational Medicinal product specific GMPs.

Review and approval of non-conformance including deviations, customer complaints, out of specification investigations.

Review and approval of control documents e.g. SOPs, quality agreements, Packaging records.

Involvement in internal, customer, regulatory inspections/audits as required.

Experience required?

An EU QP with experience in IMP's

Minimum 2 years QP experience