Qualified Person (IMPs)

Introduction

We are currently looking for a Qualified Person to release IMPs for a leading Pharmaceutical contract company based in Scotland.

Important

Must be a certified Qualified Person (QP) to release IMP

The Job

Our client are seeking a Qualified Person (QP) to join our Scottish office to provide a full QP service within the Clinical Trial Supplies division to ensure that the business and Quality objectives of our client are met.

Responsibilities:
The key responsibilities of this role are to carry out the duties of a QP as described in the Code of Practice and ensure the following:
The requirements of the Clinical Trial Authorisation/Marketing Authorisation and Manufacturing Licence are met for every batch released.
The principles and guidelines of Good Manufacturing Practice in Directive 2003/94/EC (human) are followed.
All necessary checks are performed and an account taken of production conditions and manufacturing records.
Planned changes or deviations in manufacturing/packaging and quality control are recorded in a well defined reporting system before any product is released.
Any additional sampling, inspection, tests and checks have been carried out, as appropriate to cover planned changes and deviations.
All necessary Production and Quality Control documentation have been completed and endorsed by supervisors trained in appropriate disciplines.
All Legal requirements for imported products have been met.

Qualifications:
The ideal candidate will possess a Degree in a Life Science, preferably Chemistry or Biology and significant previous experience of working in a GMP environment
Qualified Person status for Investigational Medicinal Products is required, Permanent QP status would be preferred but not essential.

To apply for this position, candidates must be eligible to live and work in the UK