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.