Lead Qualified Person

Job content

The position is lead of the QP group of Torbay Pharmaceutical’s Quality unit. The QP group acts independently to the rest of the QA unit and ensures best practices are used across the site for the manufacture of Quality, safe and efficacious products.

You will be accountable to the Quality Director for assisting in the delivery of autonomous and innovative Quality management to achieve:

This full-time role will be based at our multimillion-pound purpose-built facility in beautiful South Devon.

To act as a Qualified Person under the requirements of 2001/83/EC and 2001/20EC as translated into the Human Medicines Regulations 2012 and provide QP services to Torbay Pharmaceuticals’ manufacturing licences MIA & MIA(IMP) 13079 or be in a position to submit application within 6 months of commencement of employment

The qualified person provides a highly specialist service to ensure medicines are manufactured and the quality, safety and efficacy are risk assessed to ensure compliance with pharmaceutical legislation. The QP will work within professional boundaries and interpret data to decide independently on the suitably of medicines for patients.

Lead and manage the QP/ Release group, including other QPs, Trainee QPs, and other releasing officers.

The post holder will be required to plan and organise their work adjusting to the needs of the business and highly complex information that may require changes in prioritisation.

Torbay Pharmaceuticals (TP) is a semi-autonomous business unit of Torbay and South Devon NHS Trust with its own Management Board.

Torbay Pharmaceuticals (TP) is a flagship business within the National Health Service and manufactures and distributes terminally sterilised injectables for the secondary care market in the UK and worldwide.

The business employs circa 200 people and has sales in excess of £20M per.

TP is a holder of the following MHRA (Medicines and Healthcare Products Regulatory Agency) licenses;

• Manufacturers License
• Manufacturers License ‘Specials’
• Wholesale Dealers Licence
• Manufacturers Licence ‘Investigational Medicinal Products

TP is a holder of the following Quality Management Accreditations:

• ISO13485 – Medical Devices

2017 saw the opening of our new manufacturing plant, supported by a £26m investment. We have ambitious growth plans that will see us become a global pharmaceutical company.