Qualified Person

Location Newcastle upon Tyne, Newcastle upon Tyne, England
Discipline: Pharmaceutical
Job type: Permanent
Salary: ££70000 - £100000 per annum
Contact name: Gareth Gooley

Contact email: Gareth.Gooley@sciencesr.com
Job ref: GG2825_1631087653
Published: 13 days ago

A quickly growing pharmaceutical CDMO in the North East are currently recruiting for a Head of Quality and QP eligible to release product in accordance with article 51 of 2001/83/EC and Annex 16 of Good Manufacturing Practice Part I (Eudralex volume 4)

This vacacancy is also open to Trainee QPs; ideally with fewer than 4 modules remaining

As a Head of Quality/QP you will be a key member of the batch release team, ensuring GMP compliance throughout the site and leading QMS maintenance and improvement activities.

Responsibilities

  • Manage and lead all quality operations on site
  • To undertake routine product and IMP certification as a Qualified Person in accordance with article 51 of 2001/83/EC and Annex 16 of Good Manufacturing Practice Part I (Eudralex volume 4)
  • Lead the maintenance of GMP, GDP and GCP standards across all site operations
  • To perform the review and certification as suitable for release for sale batches of product processed at the site

Requirements

  • Registered EU Qualified Person with relevant experience within the pharmaceutical industry
  • Detailed knowledge of current GMP requirements and working knowledge of current GDP requirements
  • Good understanding of the pharmaceutical manufacturing sector in the UK, EU and third countries
  • Experience of working with electronic QMS solutions, such as Q-Pulse

Interviews for this QP vacancy are imminent so please apply now or contact Gareth Gooley at Science solutions for more information.