Qualified Person QP

Role Overview

We are currently looking for a Qualified Person (QP) to join a leading pharmaceutical business based in London. As the Qualified Person (QP) you will be responsible for the day to day batch release activities whilst ensuring GMP and GDP compliance.

Key Duties and Responsibilities

Your duties as the Qualified Person (QP) will be varied however the key duties and responsibilities are as following:

1. You will ensure that all batches are manufactured in accordance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). You will also ensure that batches and it's manufacture comply with the provisions of the marketing authorisation.

2. As the Qualified Person (QP) you will verify that all audits have been carried out as required by the Quality Assurance system and verify that all checks and test have been performed.

3. You will complete the investigation of complaints, initiating corrective and preventive actions.

4. You will also perform audits of API sites, Testing Laboratories and Release Sites whilst also performing self-inspections, ensuring compliance.

Role Requirements

To be successful in your application to this exciting opportunity as the Qualified Person (QP) we are looking to identify the following on your profile and past history:

1. Relevant degree in a Science or QA discipline and registered as a Qualified Person (QP)

2. Proven industry experience gained as a QP on a manufacturing licence as well as QMS process design, implementation, management and utilisation experience

3. A working scientific knowledge and practical experience with GMP, with the ability to interpret and translate GMP guidelines into effective processes and procedures

Key Words: QP / Qualified Person / GXP / GMP / QA / Quality / Quality Assurance / QMS / Audits / Auditing / Batch Release / Directives 2001/83/EC / Quality Management / SOP / MIA / GDP