Head of Operational Quality & Formulation
North-East
SRG is working with a leading sterile pharmaceutical company who has become a leader in specials with an ever-expanding footprint, supplying hard-to-source product to patients who need them.
They are now looking for a Head of Operational Quality & Formulation to be based at their site in the North-East Near Newcastle and oversee the formulation and Safe & timely release of life saving products.
The Role:
As the Head of Operational Quality & Formulation you will be overseeing the Quality, Formulation & Production teams ensuring GMP & regulatory compliance of manufactured specials products, making sure they are released for the patients who need them.
Key responsibilities:
* Act as the Quality Controller for the Manufacturers Specials Licence.
* Establish, review & monitor Key quality metrics and drive continuous improvement.
* Oversee new product introduction, assessing feasibility and guiding new formulations to production readiness.
* Design & oversee stability programs, pharmacovigilance systems and ensure compliance with GMP, GDP & MHRA.
* Lead investigations of deviations, complaints & root causes, implementing CAPAs.
Required:
* A degree or higher qualification/ equivalent experience in relevant scientific field.
* GPhC registration is essential.
* Proven experience in a pharmaceutical formulation, QA or manufacturing with a strong knowledge of GMP, GDP & MHRA Specials guidance.
* Strong management & project coordination skills.