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Head of Quality
2 weeks ago
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.