Qualified Person

A fantastic opportunity has become available for a Qualified Person to join a leading Biopharmaceutical company based in the Hertfordshire area. As the Qualified Person you will be responsible for ensuring GMP compliance throughout the site, whilst also being tasked with batch release duties as specified in EU Directive 2001/83/EC and 2001/82/EC.

Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:

1. You will be named as the Qualified Person on the MIA and will ensure that all products are manufactured and released in accordance with EU directive 2001/83/EC.

2. As the Qualified Person, you will be responsible for ensuring the site wide compliance against regulatory standards such as GMP. You will have full over site of the companies Quality Systems, QMS, and will manage CAPAs, Deviations, Change Controls etc.

3. As a Qualified Person, you will also work closely with the wider Quality Assurance function, providing support where applicable. Highlight significant GMP failures or any other concerns relating to product quality, safety, efficacy or compliance to senior management, including the Head of QA. Attend the quality governance meetings as directed and required.

4. Ensure that complaints, deviations, adverse events and any other significant quality incidents are thoroughly reviewed and closed out in a timely manner. Contribute to the review performance of the company quality systems. Work as part of the team to undertake continuous improvement of business quality systems

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

1. You will be degree qualified within a Scientific related discipline and recognised as a Qualified Person. The company offer a training and support function for their QPs and as such, no specific product release experience is necessary. However, a background in releasing sterile products is preferred.

2. Experience managing a Quality System within a pharmaceutical or life science business to regulatory standards.

3. Demonstrated experience in deviation and incident investigation, as well as leading EU and US competent authority inspections. You will also have the capability in leading GMP improvement programs.