Qualified Person

A leading pharmaceuticals manufacturing business based in Swindon are looking to hire a Qualified Person to support the batch release of a wide range of complex products manufactured on-site.

The new QP will join the senior quality team and will be actively involved in product release whilst also taking ownership of key areas of quality delivery and strategy for their function, as well as supporting site and group projects. As the business is a fast-paced Manufacturing Organisation with a customer focus, the successful Qualified Person will also support commercial quality operations.

Reporting into the Quality Director and working alongside a network of QA Managers and Qualified Persons within the business, this position will ensure compliance to new and established systems and global regulations whilst also driving QMS implementation and improvement.

As Qualified Person, you would have responsibility for:

  • Inclusion on the Manufacturing License as a Qualified Person
  • Product release: you will ensure that each batch is manufactured in accordance current MHRA/EU/FDA GMP Directives and the relevant marketing authorisation.
  • Ensuring compliance to new and established systems, global regulations and guidelines
  • Supporting the implementation of the site excellence program by leading and implementing improvements
  • Supporting the development of new quality system procedures and processes
  • Quality performance reporting, and support of investigations.
  • Help drive Quality culture
  • GMP and GDP compliance

Experience required:

  • Must be eligible to be named as a QP on the company license
  • Thorough knowledge of cGMPs and cGDPs for medicinal products
  • Degree in technical or science-related discipline
  • Ideally 2-3 years' experience as a releasing QP however the business will be able to quickly upskill a less experienced QP

The salary on offer for the Qualified Person is between £75,000-£85,000 with the ability to go higher for an individual with very relevant experience.

This position is a critical hire to support business growth so interviews will be held within the next 2-3 weeks ideally. If you are considering a move and this looks like it could right next step, then please apply as soon as possible to be considered for interview.

Please apply by this advert or contact James Ivall at Goodman Masson on 02073 240538 as soon as possible to ensure that you do not miss out.

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